Trial Outcomes & Findings for Strategies Using Off-Patent Antibiotics for Methicillin Resistant S. Aureus "STOP MRSA" (NCT NCT00729937)
NCT ID: NCT00729937
Last Updated: 2015-02-18
Results Overview
Clinical cure at TOC was defined as no failure on any previous visit up through the TOC, absence of fever, and resolution or minimal presence of all the following signs and symptoms from baseline based on clinician assessment of erythema, swelling, and tenderness. A participant would have been a clinical failure at the On Therapy (OTV) visit with presence of fever attributable to the infection being studied, increase in erythema by 25% or more, or worsening of both swelling and tenderness based on clinical assessment. A participant would have been a clinical failure at the End of Therapy (EOT) visit with presence of fever attributable to the infection being studied, increase or no improvement in erythema, or no improvement in either swelling or tenderness based on clinical assessment.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
2265 participants
Primary outcome timeframe
Days 14-21
Results posted on
2015-02-18
Participant Flow
Participants were recruited between 13APR2009 and 16APR2013 from those who presented with an abscess, infected wound, or cellulitis at emergency departments at each of the clinical sites.
Participant milestones
| Measure |
Abscess, Placebo
Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
|
Abscess, TMP/SMX
Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Infected Wound, TMP/SMX
Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
|
Infected Wound, Clindamycin
Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
|
Cellulitis, Cephalexin and TMP/SMX
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Cellulitis, Cephalexin
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
629
|
636
|
251
|
249
|
249
|
251
|
|
Overall Study
COMPLETED
|
555
|
548
|
222
|
215
|
221
|
214
|
|
Overall Study
NOT COMPLETED
|
74
|
88
|
29
|
34
|
28
|
37
|
Reasons for withdrawal
| Measure |
Abscess, Placebo
Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
|
Abscess, TMP/SMX
Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Infected Wound, TMP/SMX
Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
|
Infected Wound, Clindamycin
Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
|
Cellulitis, Cephalexin and TMP/SMX
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Cellulitis, Cephalexin
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
|
|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
49
|
58
|
18
|
33
|
18
|
23
|
|
Overall Study
Physician Decision
|
7
|
16
|
2
|
0
|
5
|
8
|
|
Overall Study
Death
|
1
|
0
|
1
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
5
|
6
|
0
|
4
|
2
|
|
Overall Study
Randomized but not treated
|
12
|
6
|
1
|
0
|
1
|
3
|
|
Overall Study
Did not meet eligibility criteria
|
2
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Incarcerated
|
0
|
2
|
1
|
1
|
0
|
0
|
Baseline Characteristics
Strategies Using Off-Patent Antibiotics for Methicillin Resistant S. Aureus "STOP MRSA"
Baseline characteristics by cohort
| Measure |
Abscess, Placebo
n=533 Participants
Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
|
Abscess, TMP/SMX
n=524 Participants
Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Infected Wound, TMP/SMX
n=198 Participants
Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
|
Infected Wound, Clindamycin
n=203 Participants
Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
|
Cellulitis, Cephalexin and TMP/SMX
n=218 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Cellulitis, Cephalexin
n=193 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
|
Total
n=1869 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
36.8 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
37.0 years
STANDARD_DEVIATION 12.6 • n=7 Participants
|
40.4 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
38.0 years
STANDARD_DEVIATION 13.3 • n=4 Participants
|
39.7 years
STANDARD_DEVIATION 13.3 • n=21 Participants
|
39.4 years
STANDARD_DEVIATION 13.2 • n=10 Participants
|
38.0 years
STANDARD_DEVIATION 12.9 • n=115 Participants
|
|
Age, Categorical
<=18 years
|
17 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
40 Participants
n=115 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
513 Participants
n=5 Participants
|
511 Participants
n=7 Participants
|
191 Participants
n=5 Participants
|
195 Participants
n=4 Participants
|
206 Participants
n=21 Participants
|
187 Participants
n=10 Participants
|
1803 Participants
n=115 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
26 Participants
n=115 Participants
|
|
Sex: Female, Male
Female
|
225 Participants
n=5 Participants
|
221 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
81 Participants
n=4 Participants
|
81 Participants
n=21 Participants
|
90 Participants
n=10 Participants
|
763 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
308 Participants
n=5 Participants
|
303 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
122 Participants
n=4 Participants
|
137 Participants
n=21 Participants
|
103 Participants
n=10 Participants
|
1106 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
11 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
233 Participants
n=5 Participants
|
232 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
73 Participants
n=4 Participants
|
75 Participants
n=21 Participants
|
68 Participants
n=10 Participants
|
752 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
252 Participants
n=5 Participants
|
244 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
117 Participants
n=4 Participants
|
123 Participants
n=21 Participants
|
111 Participants
n=10 Participants
|
962 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
69 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
21 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
65 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
180 Participants
n=5 Participants
|
178 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
75 Participants
n=21 Participants
|
60 Participants
n=10 Participants
|
628 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
353 Participants
n=5 Participants
|
346 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
131 Participants
n=4 Participants
|
143 Participants
n=21 Participants
|
133 Participants
n=10 Participants
|
1240 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
533 participants
n=5 Participants
|
524 participants
n=7 Participants
|
198 participants
n=5 Participants
|
203 participants
n=4 Participants
|
218 participants
n=21 Participants
|
193 participants
n=10 Participants
|
1869 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Days 14-21Population: The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.
Clinical cure at TOC was defined as no failure on any previous visit up through the TOC, absence of fever, and resolution or minimal presence of all the following signs and symptoms from baseline based on clinician assessment of erythema, swelling, and tenderness. A participant would have been a clinical failure at the On Therapy (OTV) visit with presence of fever attributable to the infection being studied, increase in erythema by 25% or more, or worsening of both swelling and tenderness based on clinical assessment. A participant would have been a clinical failure at the End of Therapy (EOT) visit with presence of fever attributable to the infection being studied, increase or no improvement in erythema, or no improvement in either swelling or tenderness based on clinical assessment.
Outcome measures
| Measure |
Abscess, Placebo
n=533 Participants
Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
|
Abscess, TMP/SMX
n=524 Participants
Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Infected Wound, TMP/SMX
n=198 Participants
Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
|
Infected Wound, Clindamycin
n=203 Participants
Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
|
Cellulitis, Cephalexin and TMP/SMX
n=218 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Cellulitis, Cephalexin
n=193 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Clinical Cure as of the Test-of-Cure (TOC) Visit in the Per Protocol Population
Clinical Cure
|
457 participants
|
487 participants
|
182 participants
|
187 participants
|
182 participants
|
165 participants
|
|
Number of Participants With Clinical Cure as of the Test-of-Cure (TOC) Visit in the Per Protocol Population
Clinical Failure
|
76 participants
|
37 participants
|
16 participants
|
16 participants
|
36 participants
|
28 participants
|
SECONDARY outcome
Timeframe: Days 14-21Population: All subjects who took at least one dose of study medication were included in the intent to treat population.
Clinical cure at TOC was defined as no failure on any previous visit up through the TOC, absence of fever, and resolution or minimal presence of all the following signs and symptoms from baseline based on clinician assessment of erythema, swelling, and tenderness. A participant would have been a clinical failure at the On Therapy (OTV) visit with presence of fever attributable to the infection being studied, increase in erythema by 25% or more, or worsening of both swelling and tenderness based on clinical assessment. A participant would have been a clinical failure at the End of Therapy (EOT) visit with presence of fever attributable to the infection being studied, increase or no improvement in erythema, or no improvement in either swelling or tenderness based on clinical assessment.
Outcome measures
| Measure |
Abscess, Placebo
n=617 Participants
Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
|
Abscess, TMP/SMX
n=630 Participants
Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Infected Wound, TMP/SMX
n=250 Participants
Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
|
Infected Wound, Clindamycin
n=249 Participants
Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
|
Cellulitis, Cephalexin and TMP/SMX
n=248 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Cellulitis, Cephalexin
n=248 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Clinical Cure as of the TOC Visit in the Intent to Treat Population
Clinical Cure
|
454 participants
|
507 participants
|
197 participants
|
198 participants
|
189 participants
|
171 participants
|
|
Number of Participants With Clinical Cure as of the TOC Visit in the Intent to Treat Population
Clinical Failure
|
163 participants
|
123 participants
|
53 participants
|
51 participants
|
59 participants
|
77 participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 3-4Population: The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.
The area of erythema was measured in square centimeters at baseline and at the on-therapy visit. For each subject, the change in area was calculated as the area at on-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.
Outcome measures
| Measure |
Abscess, Placebo
n=533 Participants
Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
|
Abscess, TMP/SMX
n=523 Participants
Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Infected Wound, TMP/SMX
n=195 Participants
Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
|
Infected Wound, Clindamycin
n=203 Participants
Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
|
Cellulitis, Cephalexin and TMP/SMX
n=217 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Cellulitis, Cephalexin
n=192 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population
No reduction
|
59 participants
|
37 participants
|
11 participants
|
17 participants
|
30 participants
|
33 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population
>0%-5% reduction
|
3 participants
|
2 participants
|
1 participants
|
1 participants
|
1 participants
|
2 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population
>5%-10% reduction
|
1 participants
|
4 participants
|
3 participants
|
0 participants
|
5 participants
|
1 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population
>10%-15% reduction
|
3 participants
|
3 participants
|
1 participants
|
3 participants
|
5 participants
|
0 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population
>15%-20% reduction
|
2 participants
|
6 participants
|
4 participants
|
5 participants
|
3 participants
|
2 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population
>20%-25% reduction
|
6 participants
|
3 participants
|
5 participants
|
2 participants
|
4 participants
|
4 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population
>25%-30% reduction
|
11 participants
|
6 participants
|
5 participants
|
3 participants
|
5 participants
|
3 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population
>30%-35% reduction
|
13 participants
|
7 participants
|
4 participants
|
5 participants
|
2 participants
|
7 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population
>35%-40% reduction
|
12 participants
|
13 participants
|
3 participants
|
3 participants
|
6 participants
|
2 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population
>40%-45% reduction
|
16 participants
|
15 participants
|
7 participants
|
6 participants
|
8 participants
|
6 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population
>45%-50% reduction
|
12 participants
|
12 participants
|
5 participants
|
6 participants
|
5 participants
|
9 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population
>50%-55% reduction
|
13 participants
|
6 participants
|
6 participants
|
6 participants
|
4 participants
|
6 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population
>55%-60% reduction
|
10 participants
|
10 participants
|
4 participants
|
2 participants
|
9 participants
|
8 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population
>60%-65% reduction
|
14 participants
|
21 participants
|
12 participants
|
6 participants
|
15 participants
|
3 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population
>65%-70% reduction
|
19 participants
|
9 participants
|
6 participants
|
5 participants
|
7 participants
|
7 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population
>70%-75% reduction
|
14 participants
|
17 participants
|
8 participants
|
7 participants
|
9 participants
|
5 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population
>75%-80% reduction
|
13 participants
|
21 participants
|
6 participants
|
16 participants
|
8 participants
|
7 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population
>80%-85% reduction
|
19 participants
|
18 participants
|
8 participants
|
3 participants
|
10 participants
|
6 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population
>85%-90% reduction
|
18 participants
|
13 participants
|
4 participants
|
8 participants
|
5 participants
|
8 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population
>90%-95% reduction
|
13 participants
|
16 participants
|
5 participants
|
10 participants
|
5 participants
|
6 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population
>95%-100% reduction
|
262 participants
|
284 participants
|
87 participants
|
89 participants
|
71 participants
|
67 participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 3-4Population: All subjects who took at least one dose of study medication were included in the intent to treat population.
The area of erythema was measured in square centimeters at baseline and at the on-therapy visit. For each subject, the change in area was calculated as the area at on-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.
Outcome measures
| Measure |
Abscess, Placebo
n=604 Participants
Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
|
Abscess, TMP/SMX
n=599 Participants
Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Infected Wound, TMP/SMX
n=237 Participants
Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
|
Infected Wound, Clindamycin
n=241 Participants
Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
|
Cellulitis, Cephalexin and TMP/SMX
n=237 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Cellulitis, Cephalexin
n=230 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population
No reduction
|
67 participants
|
43 participants
|
12 participants
|
18 participants
|
34 participants
|
41 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population
>0%-5% reduction
|
3 participants
|
2 participants
|
1 participants
|
1 participants
|
1 participants
|
2 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population
>5%-10% reduction
|
2 participants
|
4 participants
|
3 participants
|
1 participants
|
6 participants
|
1 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population
>10%-15% reduction
|
3 participants
|
3 participants
|
1 participants
|
4 participants
|
5 participants
|
0 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population
>15%-20% reduction
|
2 participants
|
7 participants
|
4 participants
|
5 participants
|
5 participants
|
2 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population
>20%-25% reduction
|
7 participants
|
5 participants
|
6 participants
|
3 participants
|
4 participants
|
5 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population
>25%-30% reduction
|
12 participants
|
6 participants
|
5 participants
|
4 participants
|
5 participants
|
3 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population
>30%-35% reduction
|
13 participants
|
8 participants
|
5 participants
|
6 participants
|
4 participants
|
7 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population
>35%-40% reduction
|
12 participants
|
15 participants
|
3 participants
|
4 participants
|
6 participants
|
6 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population
>40%-45% reduction
|
20 participants
|
17 participants
|
8 participants
|
7 participants
|
9 participants
|
6 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population
>45%-50% reduction
|
13 participants
|
15 participants
|
6 participants
|
6 participants
|
5 participants
|
10 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population
>50%-55% reduction
|
14 participants
|
7 participants
|
7 participants
|
8 participants
|
4 participants
|
9 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population
>55%-60% reduction
|
12 participants
|
11 participants
|
4 participants
|
2 participants
|
9 participants
|
8 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population
>60%-65% reduction
|
15 participants
|
24 participants
|
12 participants
|
7 participants
|
16 participants
|
4 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population
>65%-70% reduction
|
21 participants
|
10 participants
|
7 participants
|
6 participants
|
7 participants
|
9 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population
>70%-75% reduction
|
18 participants
|
20 participants
|
10 participants
|
9 participants
|
11 participants
|
6 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population
>75%-80% reduction
|
17 participants
|
22 participants
|
11 participants
|
17 participants
|
9 participants
|
8 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population
>80%-85% reduction
|
20 participants
|
20 participants
|
9 participants
|
3 participants
|
11 participants
|
6 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population
>85%-90% reduction
|
20 participants
|
16 participants
|
5 participants
|
11 participants
|
6 participants
|
9 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population
>90%-95% reduction
|
15 participants
|
16 participants
|
7 participants
|
11 participants
|
6 participants
|
8 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population
>95%-100% reduction
|
298 participants
|
328 participants
|
111 participants
|
108 participants
|
74 participants
|
80 participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 8-10Population: The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.
The area of erythema was measured in square centimeters at baseline and at the end-of-therapy visit. For each subject, the change in area was calculated as the area at end-of-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.
Outcome measures
| Measure |
Abscess, Placebo
n=527 Participants
Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
|
Abscess, TMP/SMX
n=520 Participants
Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Infected Wound, TMP/SMX
n=193 Participants
Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
|
Infected Wound, Clindamycin
n=200 Participants
Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
|
Cellulitis, Cephalexin and TMP/SMX
n=212 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Cellulitis, Cephalexin
n=190 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population
No reduction
|
4 participants
|
3 participants
|
3 participants
|
3 participants
|
5 participants
|
5 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population
>0%-5% reduction
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population
>5%-10% reduction
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population
>10%-15% reduction
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population
>15%-20% reduction
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population
>20%-25% reduction
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population
>25%-30% reduction
|
2 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population
>30%-35% reduction
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population
>35%-40% reduction
|
2 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population
>40%-45% reduction
|
0 participants
|
3 participants
|
2 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population
>45%-50% reduction
|
2 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population
>50%-55% reduction
|
4 participants
|
1 participants
|
2 participants
|
1 participants
|
0 participants
|
2 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population
>55%-60% reduction
|
0 participants
|
5 participants
|
1 participants
|
1 participants
|
1 participants
|
2 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population
>60%-65% reduction
|
1 participants
|
0 participants
|
3 participants
|
2 participants
|
5 participants
|
1 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population
>65%-70% reduction
|
4 participants
|
3 participants
|
2 participants
|
1 participants
|
2 participants
|
2 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population
>70%-75% reduction
|
3 participants
|
2 participants
|
3 participants
|
0 participants
|
5 participants
|
2 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population
>75%-80% reduction
|
6 participants
|
2 participants
|
2 participants
|
1 participants
|
2 participants
|
2 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population
>80%-85% reduction
|
4 participants
|
5 participants
|
1 participants
|
3 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population
>85%-90% reduction
|
7 participants
|
7 participants
|
1 participants
|
4 participants
|
4 participants
|
4 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population
>90%-95% reduction
|
9 participants
|
7 participants
|
3 participants
|
1 participants
|
1 participants
|
4 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population
>95%-100% reduction
|
478 participants
|
478 participants
|
167 participants
|
182 participants
|
183 participants
|
162 participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 8-10Population: All subjects who took at least one dose of study medication were included in the intent to treat population.
The area of erythema was measured in square centimeters at baseline and at the end-of-therapy visit. For each subject, the change in area was calculated as the area at end-of-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.
Outcome measures
| Measure |
Abscess, Placebo
n=582 Participants
Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
|
Abscess, TMP/SMX
n=576 Participants
Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Infected Wound, TMP/SMX
n=228 Participants
Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
|
Infected Wound, Clindamycin
n=231 Participants
Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
|
Cellulitis, Cephalexin and TMP/SMX
n=229 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Cellulitis, Cephalexin
n=225 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population
No reduction
|
5 participants
|
3 participants
|
3 participants
|
3 participants
|
5 participants
|
5 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population
>0%-5% reduction
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population
>5%-10% reduction
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population
>10%-15% reduction
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population
>15%-20% reduction
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population
>20%-25% reduction
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population
>25%-30% reduction
|
2 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population
>30%-35% reduction
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population
>35%-40% reduction
|
2 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population
>40%-45% reduction
|
0 participants
|
3 participants
|
3 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population
>45%-50% reduction
|
2 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population
>50%-55% reduction
|
4 participants
|
1 participants
|
2 participants
|
1 participants
|
0 participants
|
2 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population
>55%-60% reduction
|
0 participants
|
5 participants
|
1 participants
|
1 participants
|
1 participants
|
2 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population
>60%-65% reduction
|
2 participants
|
0 participants
|
3 participants
|
2 participants
|
5 participants
|
2 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population
>65%-70% reduction
|
4 participants
|
3 participants
|
2 participants
|
1 participants
|
2 participants
|
3 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population
>70%-75% reduction
|
3 participants
|
2 participants
|
3 participants
|
2 participants
|
5 participants
|
2 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population
>75%-80% reduction
|
6 participants
|
2 participants
|
2 participants
|
1 participants
|
3 participants
|
2 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population
>80%-85% reduction
|
4 participants
|
5 participants
|
1 participants
|
4 participants
|
0 participants
|
2 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population
>85%-90% reduction
|
7 participants
|
9 participants
|
2 participants
|
4 participants
|
4 participants
|
6 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population
>90%-95% reduction
|
9 participants
|
7 participants
|
5 participants
|
2 participants
|
2 participants
|
7 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population
>95%-100% reduction
|
531 participants
|
532 participants
|
197 participants
|
208 participants
|
198 participants
|
188 participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 14-21Population: The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.
The area of erythema was measured in square centimeters at baseline and at the TOC visit. For each subject, the change in area was calculated as the area at TOC subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.
Outcome measures
| Measure |
Abscess, Placebo
n=532 Participants
Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
|
Abscess, TMP/SMX
n=521 Participants
Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Infected Wound, TMP/SMX
n=197 Participants
Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
|
Infected Wound, Clindamycin
n=201 Participants
Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
|
Cellulitis, Cephalexin and TMP/SMX
n=215 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Cellulitis, Cephalexin
n=192 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population
No reduction
|
2 participants
|
0 participants
|
1 participants
|
1 participants
|
2 participants
|
0 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population
>0%-5% reduction
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population
>5%-10% reduction
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population
>10%-15% reduction
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population
>15%-20% reduction
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population
>20%-25% reduction
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population
>25%-30% reduction
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population
>30%-35% reduction
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population
>35%-40% reduction
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population
>40%-45% reduction
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population
>45%-50% reduction
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population
>50%-55% reduction
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population
>55%-60% reduction
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population
>60%-65% reduction
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population
>65%-70% reduction
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population
>70%-75% reduction
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
2 participants
|
1 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population
>75%-80% reduction
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population
>80%-85% reduction
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population
>85%-90% reduction
|
4 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population
>90%-95% reduction
|
4 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population
>95%-100% reduction
|
520 participants
|
516 participants
|
191 participants
|
199 participants
|
207 participants
|
189 participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 14-21Population: All subjects who took at least one dose of study medication were included in the intent to treat population.
The area of erythema was measured in square centimeters at baseline and at the TOC visit. For each subject, the change in area was calculated as the area at TOC subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.
Outcome measures
| Measure |
Abscess, Placebo
n=573 Participants
Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
|
Abscess, TMP/SMX
n=565 Participants
Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Infected Wound, TMP/SMX
n=223 Participants
Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
|
Infected Wound, Clindamycin
n=223 Participants
Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
|
Cellulitis, Cephalexin and TMP/SMX
n=228 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Cellulitis, Cephalexin
n=221 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population
>45%-50% reduction
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population
>50%-55% reduction
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population
>55%-60% reduction
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population
>60%-65% reduction
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population
>65%-70% reduction
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population
>70%-75% reduction
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
2 participants
|
1 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population
>75%-80% reduction
|
2 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population
>80%-85% reduction
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population
>85%-90% reduction
|
4 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population
>90%-95% reduction
|
4 participants
|
1 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population
>95%-100% reduction
|
561 participants
|
559 participants
|
216 participants
|
219 participants
|
220 participants
|
217 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population
No reduction
|
2 participants
|
0 participants
|
1 participants
|
1 participants
|
2 participants
|
0 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population
>0%-5% reduction
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population
>5%-10% reduction
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population
>10%-15% reduction
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population
>15%-20% reduction
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population
>20%-25% reduction
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population
>25%-30% reduction
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population
>30%-35% reduction
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population
>35%-40% reduction
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population
>40%-45% reduction
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 14-21Population: The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.
Participants were categorized as composite clinical cure if they had resolution of all symptoms/signs of infection, or improvement to such an extent that no additional antibiotic therapy and/or surgical procedures were necessary. Participants were categorized as composite clinical failure if they had lack of resolution of all signs and symptoms of infection to such an extent that further antibiotic therapy and/or surgical procedures were necessary.
Outcome measures
| Measure |
Abscess, Placebo
n=533 Participants
Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
|
Abscess, TMP/SMX
n=524 Participants
Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Infected Wound, TMP/SMX
n=198 Participants
Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
|
Infected Wound, Clindamycin
n=203 Participants
Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
|
Cellulitis, Cephalexin and TMP/SMX
n=218 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Cellulitis, Cephalexin
n=193 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
|
|---|---|---|---|---|---|---|
|
Number of Participants by Composite Clinical Outcome at the TOC Visit in the Per Protocol Population
Composite Clinical Cure
|
396 participants
|
453 participants
|
113 participants
|
114 participants
|
160 participants
|
149 participants
|
|
Number of Participants by Composite Clinical Outcome at the TOC Visit in the Per Protocol Population
Composite Clinical Failure
|
137 participants
|
71 participants
|
85 participants
|
89 participants
|
58 participants
|
44 participants
|
SECONDARY outcome
Timeframe: Day 14-21Population: The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.
Participants were categorized for the microbiological outcome with Presumed eradication if they were not deemed a clinical failure through TOC. Those who were deemed a clinical failure through the TOC were classified as one of the following: Persistence=persistent growth of a pre-therapy pathogen; New infection=growth of a new pathogen and eradication of initial pathogen; Super-infection=growth of a new pathogen in addition to persistent growth of pre-therapy pathogen; Unclassified=no specimen for culture or growth of a pathogen in subsequent culture specimen of cellulitis participants, or for whom initial culture specimens were negative or were not obtained for infected wound and abscess participants; or Indeterminate=not meeting any one of the above microbiologic outcome criteria.
Outcome measures
| Measure |
Abscess, Placebo
n=533 Participants
Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
|
Abscess, TMP/SMX
n=524 Participants
Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Infected Wound, TMP/SMX
n=198 Participants
Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
|
Infected Wound, Clindamycin
n=203 Participants
Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
|
Cellulitis, Cephalexin and TMP/SMX
n=218 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Cellulitis, Cephalexin
n=193 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Each Microbiological Outcome at the TOC Visit in the Per Protocol Population
Presumed eradication
|
457 participants
|
487 participants
|
182 participants
|
187 participants
|
182 participants
|
165 participants
|
|
Number of Participants With Each Microbiological Outcome at the TOC Visit in the Per Protocol Population
Persistence
|
39 participants
|
15 participants
|
5 participants
|
6 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Each Microbiological Outcome at the TOC Visit in the Per Protocol Population
New infection
|
1 participants
|
0 participants
|
2 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Each Microbiological Outcome at the TOC Visit in the Per Protocol Population
Super-infection
|
8 participants
|
4 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Each Microbiological Outcome at the TOC Visit in the Per Protocol Population
Unclassified
|
28 participants
|
18 participants
|
9 participants
|
9 participants
|
13 participants
|
11 participants
|
|
Number of Participants With Each Microbiological Outcome at the TOC Visit in the Per Protocol Population
Indeterminate
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
23 participants
|
17 participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 14-21Population: The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.
All surgical procedures such as incision and drainage (I\&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I\&D of an abscess for participants in the abscess or infected wound arms, were recorded. Participants who required a surgical intervention between the initial enrollment (excluding the initial I\&D as applicable) and the test-of-cure visit are summarized.
Outcome measures
| Measure |
Abscess, Placebo
n=533 Participants
Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
|
Abscess, TMP/SMX
n=524 Participants
Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Infected Wound, TMP/SMX
n=198 Participants
Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
|
Infected Wound, Clindamycin
n=203 Participants
Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
|
Cellulitis, Cephalexin and TMP/SMX
n=218 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Cellulitis, Cephalexin
n=193 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
|
|---|---|---|---|---|---|---|
|
Number of Participants Requiring Surgical Intervention Through the TOC Visit in the Per Protocol Population
|
46 participants
|
18 participants
|
13 participants
|
6 participants
|
26 participants
|
17 participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 14-21Population: All subjects who took at least one dose of study medication were included in the intent to treat population.
All surgical procedures such as incision and drainage (I\&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I\&D of an abscess for participants in the abscess or infected wound arms, were recorded. Participants who required a surgical intervention between the initial enrollment (excluding the initial I\&D as applicable) and the test-of-cure visit are summarized.
Outcome measures
| Measure |
Abscess, Placebo
n=617 Participants
Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
|
Abscess, TMP/SMX
n=630 Participants
Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Infected Wound, TMP/SMX
n=250 Participants
Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
|
Infected Wound, Clindamycin
n=249 Participants
Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
|
Cellulitis, Cephalexin and TMP/SMX
n=248 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Cellulitis, Cephalexin
n=248 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
|
|---|---|---|---|---|---|---|
|
Number of Participants Requiring Surgical Intervention Through the TOC Visit in the Intent to Treat Population
|
52 participants
|
25 participants
|
16 participants
|
9 participants
|
26 participants
|
28 participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 49-63Population: The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.
All surgical procedures such as incision and drainage (I\&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I\&D of an abscess for participants in the abscess or infected wound arms, were recorded. Participants who required a surgical intervention between the initial enrollment (excluding the initial I\&D as applicable) and the extended follow-up visit are summarized.
Outcome measures
| Measure |
Abscess, Placebo
n=533 Participants
Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
|
Abscess, TMP/SMX
n=524 Participants
Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Infected Wound, TMP/SMX
n=198 Participants
Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
|
Infected Wound, Clindamycin
n=203 Participants
Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
|
Cellulitis, Cephalexin and TMP/SMX
n=218 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Cellulitis, Cephalexin
n=193 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
|
|---|---|---|---|---|---|---|
|
Number of Participants Requiring Surgical Intervention Through the Extended Follow-up Visit (EFV) in the Per Protocol Population
|
69 participants
|
42 participants
|
17 participants
|
8 participants
|
33 participants
|
20 participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 49-63Population: All subjects who took at least one dose of study medication were included in the intent to treat population.
All surgical procedures such as incision and drainage (I\&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I\&D of an abscess for participants in the abscess or infected wound arms, were recorded. Participants who required a surgical intervention between the initial enrollment (excluding the initial I\&D as applicable) and the extended follow-up visit are summarized.
Outcome measures
| Measure |
Abscess, Placebo
n=617 Participants
Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
|
Abscess, TMP/SMX
n=630 Participants
Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Infected Wound, TMP/SMX
n=250 Participants
Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
|
Infected Wound, Clindamycin
n=249 Participants
Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
|
Cellulitis, Cephalexin and TMP/SMX
n=248 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Cellulitis, Cephalexin
n=248 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
|
|---|---|---|---|---|---|---|
|
Number of Participants Requiring Surgical Intervention Through the Extended Follow-up Visit (EFV) in the Intent to Treat Population
|
76 participants
|
52 participants
|
20 participants
|
12 participants
|
33 participants
|
31 participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 14-21Population: The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.
Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia. A positive response to at least one finding was considered invasive infection for this outcome measure.
Outcome measures
| Measure |
Abscess, Placebo
n=533 Participants
Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
|
Abscess, TMP/SMX
n=524 Participants
Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Infected Wound, TMP/SMX
n=198 Participants
Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
|
Infected Wound, Clindamycin
n=203 Participants
Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
|
Cellulitis, Cephalexin and TMP/SMX
n=218 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Cellulitis, Cephalexin
n=193 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Development of an Invasive Infection Through the TOC Visit in the Per Protocol Population
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 14-21Population: All subjects who took at least one dose of study medication were included in the intent to treat population.
Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia. A positive response to at least one finding was considered invasive infection for this outcome measure.
Outcome measures
| Measure |
Abscess, Placebo
n=617 Participants
Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
|
Abscess, TMP/SMX
n=630 Participants
Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Infected Wound, TMP/SMX
n=250 Participants
Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
|
Infected Wound, Clindamycin
n=249 Participants
Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
|
Cellulitis, Cephalexin and TMP/SMX
n=248 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Cellulitis, Cephalexin
n=248 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Development of an Invasive Infection Through the TOC Visit in the Intent to Treat Population
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 49-63Population: The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.
Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia. A positive response to at least one finding was considered invasive infection for this outcome measure.
Outcome measures
| Measure |
Abscess, Placebo
n=533 Participants
Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
|
Abscess, TMP/SMX
n=524 Participants
Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Infected Wound, TMP/SMX
n=198 Participants
Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
|
Infected Wound, Clindamycin
n=203 Participants
Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
|
Cellulitis, Cephalexin and TMP/SMX
n=218 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Cellulitis, Cephalexin
n=193 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Development of an Invasive Infection Through the EFV Visit in the Per Protocol Population
|
2 participants
|
2 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 49-63Population: All subjects who took at least one dose of study medication were included in the intent to treat population.
Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia. A positive response to at least one finding was considered invasive infection for this outcome measure.
Outcome measures
| Measure |
Abscess, Placebo
n=617 Participants
Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
|
Abscess, TMP/SMX
n=630 Participants
Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Infected Wound, TMP/SMX
n=250 Participants
Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
|
Infected Wound, Clindamycin
n=249 Participants
Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
|
Cellulitis, Cephalexin and TMP/SMX
n=248 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Cellulitis, Cephalexin
n=248 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Development of an Invasive Infection Through the EFV Visit in the Intent to Treat Population
|
3 participants
|
2 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 14-21Population: The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.
Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site. Participants who were reported to have developed a recurrent infection though the test-of-cure visit are summarized.
Outcome measures
| Measure |
Abscess, Placebo
n=533 Participants
Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
|
Abscess, TMP/SMX
n=524 Participants
Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Infected Wound, TMP/SMX
n=198 Participants
Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
|
Infected Wound, Clindamycin
n=203 Participants
Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
|
Cellulitis, Cephalexin and TMP/SMX
n=218 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Cellulitis, Cephalexin
n=193 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the TOC Visit in the Per Protocol Population
|
16 participants
|
11 participants
|
13 participants
|
3 participants
|
30 participants
|
22 participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 14-21Population: All subjects who took at least one dose of study medication were included in the intent to treat population.
Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site. Participants who were reported to have developed a recurrent infection though the test-of-cure visit are summarized.
Outcome measures
| Measure |
Abscess, Placebo
n=617 Participants
Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
|
Abscess, TMP/SMX
n=630 Participants
Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Infected Wound, TMP/SMX
n=250 Participants
Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
|
Infected Wound, Clindamycin
n=249 Participants
Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
|
Cellulitis, Cephalexin and TMP/SMX
n=248 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Cellulitis, Cephalexin
n=248 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the TOC Visit in the Intent to Treat Population
|
17 participants
|
13 participants
|
15 participants
|
4 participants
|
32 participants
|
29 participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 49-63Population: The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.
Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site. Participants who were reported to have developed a recurrent infection though the extended follow-up visit are summarized.
Outcome measures
| Measure |
Abscess, Placebo
n=533 Participants
Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
|
Abscess, TMP/SMX
n=524 Participants
Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Infected Wound, TMP/SMX
n=198 Participants
Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
|
Infected Wound, Clindamycin
n=203 Participants
Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
|
Cellulitis, Cephalexin and TMP/SMX
n=218 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Cellulitis, Cephalexin
n=193 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the EFV Visit in the Per Protocol Population
|
23 participants
|
26 participants
|
14 participants
|
4 participants
|
33 participants
|
24 participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 49-63Population: All subjects who took at least one dose of study medication were included in the intent to treat population.
Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site. Participants who were reported to have developed a recurrent infection though the extended follow-up visit are summarized.
Outcome measures
| Measure |
Abscess, Placebo
n=617 Participants
Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
|
Abscess, TMP/SMX
n=630 Participants
Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Infected Wound, TMP/SMX
n=250 Participants
Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
|
Infected Wound, Clindamycin
n=249 Participants
Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
|
Cellulitis, Cephalexin and TMP/SMX
n=248 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Cellulitis, Cephalexin
n=248 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the EFV Visit in the Intent to Treat Population
|
26 participants
|
30 participants
|
16 participants
|
6 participants
|
35 participants
|
31 participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 14-21Population: The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.
At each follow-up visit, participants were asked about history of skin infections in household members (e.g., similar skin infection in a family member). This outcome measure relied solely on participant reporting. Participants who reported having a family member with a similar infection though the test-of-cure visit are summarized.
Outcome measures
| Measure |
Abscess, Placebo
n=533 Participants
Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
|
Abscess, TMP/SMX
n=524 Participants
Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Infected Wound, TMP/SMX
n=198 Participants
Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
|
Infected Wound, Clindamycin
n=203 Participants
Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
|
Cellulitis, Cephalexin and TMP/SMX
n=218 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Cellulitis, Cephalexin
n=193 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Infections in Household Contacts Through the TOC Visit in the Per Protocol Population
|
22 participants
|
9 participants
|
1 participants
|
5 participants
|
6 participants
|
4 participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 14-21Population: All subjects who took at least one dose of study medication were included in the intent to treat population.
At each follow-up visit, participants were asked about history of skin infections in household members (e.g., similar skin infection in a family member). This outcome measure relied solely on participant reporting. Participants who reported having a family member with a similar infection though the test-of-cure visit are summarized.
Outcome measures
| Measure |
Abscess, Placebo
n=617 Participants
Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
|
Abscess, TMP/SMX
n=630 Participants
Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Infected Wound, TMP/SMX
n=250 Participants
Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
|
Infected Wound, Clindamycin
n=249 Participants
Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
|
Cellulitis, Cephalexin and TMP/SMX
n=248 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Cellulitis, Cephalexin
n=248 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Infections in Household Contacts Through the TOC Visit in the Intent to Treat Population
|
22 participants
|
12 participants
|
1 participants
|
6 participants
|
7 participants
|
4 participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 49-63Population: The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.
At each follow-up visit, participants were asked about history of skin infections in household members (e.g., similar skin infection in a family member). This outcome measure relied solely on participant reporting. Participants who reported having a family member with a similar infection though the extended follow-up visit are summarized.
Outcome measures
| Measure |
Abscess, Placebo
n=533 Participants
Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
|
Abscess, TMP/SMX
n=524 Participants
Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Infected Wound, TMP/SMX
n=198 Participants
Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
|
Infected Wound, Clindamycin
n=203 Participants
Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
|
Cellulitis, Cephalexin and TMP/SMX
n=218 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Cellulitis, Cephalexin
n=193 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Infections in Household Contacts Through the EFV Visit in the Per Protocol Population
|
33 participants
|
20 participants
|
6 participants
|
9 participants
|
10 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 49-63Population: All subjects who took at least one dose of study medication were included in the intent to treat population.
At each follow-up visit, participants were asked about history of skin infections in household members (e.g., similar skin infection in a family member). This outcome measure relied solely on participant reporting. Participants who reported having a family member with a similar infection though the extended follow-up visit are summarized.
Outcome measures
| Measure |
Abscess, Placebo
n=617 Participants
Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
|
Abscess, TMP/SMX
n=630 Participants
Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Infected Wound, TMP/SMX
n=250 Participants
Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
|
Infected Wound, Clindamycin
n=249 Participants
Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
|
Cellulitis, Cephalexin and TMP/SMX
n=248 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Cellulitis, Cephalexin
n=248 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Infections in Household Contacts Through the EFV Visit in the Intent to Treat Population
|
35 participants
|
25 participants
|
6 participants
|
11 participants
|
11 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 49-63Population: All subjects who took at least one dose of study medication were included in the intent to treat population.
All adverse events were recorded through the test of cure visit; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit. All AEs were assessed for association with the study product by a clinician and were considered associated with study product if the event was temporally related to the administration of the study product and no other etiology more likely explains the event. Associated adverse events are summarized by MedDRA System Organ Class.
Outcome measures
| Measure |
Abscess, Placebo
n=617 Participants
Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
|
Abscess, TMP/SMX
n=630 Participants
Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Infected Wound, TMP/SMX
n=250 Participants
Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
|
Infected Wound, Clindamycin
n=249 Participants
Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
|
Cellulitis, Cephalexin and TMP/SMX
n=248 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Cellulitis, Cephalexin
n=248 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class
Cardiac disorders
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class
Eye disorders
|
3 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class
Gastrointestinal disorders
|
164 participants
|
198 participants
|
82 participants
|
93 participants
|
87 participants
|
73 participants
|
|
Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class
General disorders and administration site conditio
|
6 participants
|
11 participants
|
3 participants
|
1 participants
|
2 participants
|
2 participants
|
|
Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class
Infections and infestations
|
5 participants
|
4 participants
|
1 participants
|
1 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class
Injury, poisoning and procedural complications
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class
Investigations
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class
Metabolism and nutrition disorders
|
7 participants
|
11 participants
|
2 participants
|
4 participants
|
3 participants
|
0 participants
|
|
Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class
Musculoskeletal and connective tissue disorders
|
3 participants
|
3 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class
Nervous system disorders
|
38 participants
|
44 participants
|
16 participants
|
15 participants
|
16 participants
|
20 participants
|
|
Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class
Psychiatric disorders
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class
Renal and urinary disorders
|
2 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class
Reproductive system and breast disorders
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class
Respiratory, thoracic and mediastinal disorders
|
3 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class
Skin and subcutaneous tissue disorders
|
10 participants
|
14 participants
|
5 participants
|
6 participants
|
15 participants
|
7 participants
|
|
Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class
Vascular disorders
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 1 through 14Population: The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.
As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as participation in normal life activities. The maximum number of days assessed, 14, was assigned to participants who had not yet resumed normal activities by the end of the assessment period.
Outcome measures
| Measure |
Abscess, Placebo
n=524 Participants
Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
|
Abscess, TMP/SMX
n=515 Participants
Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Infected Wound, TMP/SMX
n=196 Participants
Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
|
Infected Wound, Clindamycin
n=201 Participants
Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
|
Cellulitis, Cephalexin and TMP/SMX
n=217 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Cellulitis, Cephalexin
n=193 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
|
|---|---|---|---|---|---|---|
|
Mean Days Missed From Normal Activities in the Per Protocol Population
|
2.6 days
Standard Deviation 3.8
|
2.0 days
Standard Deviation 3.1
|
2.7 days
Standard Deviation 4.1
|
2.1 days
Standard Deviation 3.5
|
2.2 days
Standard Deviation 3.2
|
2.5 days
Standard Deviation 3.9
|
SECONDARY outcome
Timeframe: Day 1 through 14Population: All subjects who took at least one dose of study medication were included in the intent to treat population.
As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as participation in normal life activities. The maximum number of days assessed, 14, was assigned to participants who had not yet resumed normal activities by the end of the assessment period.
Outcome measures
| Measure |
Abscess, Placebo
n=585 Participants
Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
|
Abscess, TMP/SMX
n=584 Participants
Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Infected Wound, TMP/SMX
n=234 Participants
Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
|
Infected Wound, Clindamycin
n=238 Participants
Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
|
Cellulitis, Cephalexin and TMP/SMX
n=236 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Cellulitis, Cephalexin
n=230 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
|
|---|---|---|---|---|---|---|
|
Mean Days Missed From Normal Activities in the Intent to Treat Population
|
2.5 days
Standard Deviation 3.7
|
2.1 days
Standard Deviation 3.2
|
2.6 days
Standard Deviation 4.0
|
2.1 days
Standard Deviation 3.4
|
2.2 days
Standard Deviation 3.2
|
2.7 days
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: Day 1 through 14Population: The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.
As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as use of other, non-study medications such as analgesics. Each participant is summarized by the last day of reported analgesic usage, from the start of treatment with study intervention. The maximum number of days assessed, 14, was assigned to participants who were still taking analgesic medications by the end of the assessment period.
Outcome measures
| Measure |
Abscess, Placebo
n=533 Participants
Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
|
Abscess, TMP/SMX
n=524 Participants
Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Infected Wound, TMP/SMX
n=198 Participants
Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
|
Infected Wound, Clindamycin
n=203 Participants
Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
|
Cellulitis, Cephalexin and TMP/SMX
n=218 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Cellulitis, Cephalexin
n=193 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
|
|---|---|---|---|---|---|---|
|
Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population
Day 1
|
44 participants
|
56 participants
|
23 participants
|
29 participants
|
14 participants
|
17 participants
|
|
Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population
Day 2
|
37 participants
|
32 participants
|
11 participants
|
9 participants
|
7 participants
|
5 participants
|
|
Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population
Day 3
|
41 participants
|
49 participants
|
17 participants
|
18 participants
|
13 participants
|
7 participants
|
|
Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population
Day 4
|
39 participants
|
32 participants
|
14 participants
|
9 participants
|
15 participants
|
7 participants
|
|
Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population
Day 5
|
24 participants
|
40 participants
|
7 participants
|
9 participants
|
9 participants
|
4 participants
|
|
Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population
Day 6
|
29 participants
|
27 participants
|
10 participants
|
11 participants
|
9 participants
|
19 participants
|
|
Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population
Day 7
|
24 participants
|
27 participants
|
10 participants
|
12 participants
|
9 participants
|
6 participants
|
|
Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population
Day 8
|
31 participants
|
35 participants
|
7 participants
|
10 participants
|
9 participants
|
5 participants
|
|
Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population
Day 9
|
22 participants
|
21 participants
|
3 participants
|
7 participants
|
9 participants
|
4 participants
|
|
Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population
Day 10
|
12 participants
|
13 participants
|
5 participants
|
4 participants
|
4 participants
|
3 participants
|
|
Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population
Day 11
|
16 participants
|
10 participants
|
2 participants
|
4 participants
|
3 participants
|
1 participants
|
|
Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population
Day 12
|
18 participants
|
12 participants
|
4 participants
|
1 participants
|
1 participants
|
6 participants
|
|
Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population
Day 13
|
12 participants
|
3 participants
|
2 participants
|
6 participants
|
2 participants
|
2 participants
|
|
Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population
Day 14
|
130 participants
|
107 participants
|
46 participants
|
40 participants
|
45 participants
|
38 participants
|
SECONDARY outcome
Timeframe: Day 1 through 14Population: All subjects who took at least one dose of study medication were included in the intent to treat population.
As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as use of other, non-study medications such as analgesics. Each participant is summarized by the last day of reported analgesic usage, from the start of treatment with study intervention. The maximum number of days assessed, 14, was assigned to participants who were still taking analgesic medications by the end of the assessment period.
Outcome measures
| Measure |
Abscess, Placebo
n=617 Participants
Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
|
Abscess, TMP/SMX
n=630 Participants
Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Infected Wound, TMP/SMX
n=250 Participants
Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
|
Infected Wound, Clindamycin
n=249 Participants
Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
|
Cellulitis, Cephalexin and TMP/SMX
n=248 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Cellulitis, Cephalexin
n=248 Participants
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
|
|---|---|---|---|---|---|---|
|
Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population
Day 14
|
146 participants
|
127 participants
|
59 participants
|
50 participants
|
51 participants
|
45 participants
|
|
Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population
Day 2
|
38 participants
|
34 participants
|
15 participants
|
10 participants
|
7 participants
|
6 participants
|
|
Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population
Day 3
|
45 participants
|
64 participants
|
18 participants
|
24 participants
|
15 participants
|
10 participants
|
|
Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population
Day 4
|
47 participants
|
34 participants
|
16 participants
|
10 participants
|
16 participants
|
13 participants
|
|
Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population
Day 1
|
58 participants
|
81 participants
|
32 participants
|
37 participants
|
18 participants
|
28 participants
|
|
Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population
Day 5
|
27 participants
|
42 participants
|
9 participants
|
9 participants
|
10 participants
|
4 participants
|
|
Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population
Day 6
|
34 participants
|
29 participants
|
13 participants
|
13 participants
|
10 participants
|
22 participants
|
|
Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population
Day 7
|
27 participants
|
32 participants
|
13 participants
|
12 participants
|
9 participants
|
8 participants
|
|
Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population
Day 8
|
34 participants
|
40 participants
|
8 participants
|
11 participants
|
10 participants
|
6 participants
|
|
Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population
Day 9
|
24 participants
|
26 participants
|
4 participants
|
9 participants
|
9 participants
|
6 participants
|
|
Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population
Day 10
|
14 participants
|
15 participants
|
6 participants
|
4 participants
|
5 participants
|
4 participants
|
|
Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population
Day 11
|
19 participants
|
10 participants
|
2 participants
|
4 participants
|
3 participants
|
2 participants
|
|
Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population
Day 12
|
19 participants
|
14 participants
|
4 participants
|
3 participants
|
1 participants
|
6 participants
|
|
Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population
Day 13
|
15 participants
|
5 participants
|
2 participants
|
7 participants
|
2 participants
|
3 participants
|
Adverse Events
Abscess, Placebo
Serious events: 30 serious events
Other events: 331 other events
Deaths: 0 deaths
Abscess, TMP/SMX
Serious events: 21 serious events
Other events: 345 other events
Deaths: 0 deaths
Infected Wound, TMP/SMX
Serious events: 15 serious events
Other events: 138 other events
Deaths: 0 deaths
Infected Wound, Clindamycin
Serious events: 11 serious events
Other events: 127 other events
Deaths: 0 deaths
Cellulitis, Cephalexin and TMP/SMX
Serious events: 20 serious events
Other events: 157 other events
Deaths: 0 deaths
Cellulitis, Cephalexin
Serious events: 21 serious events
Other events: 149 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Abscess, Placebo
n=617 participants at risk
Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
|
Abscess, TMP/SMX
n=630 participants at risk
Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Infected Wound, TMP/SMX
n=250 participants at risk
Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
|
Infected Wound, Clindamycin
n=249 participants at risk
Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
|
Cellulitis, Cephalexin and TMP/SMX
n=248 participants at risk
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Cellulitis, Cephalexin
n=248 participants at risk
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/617 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.16%
1/630 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/250 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/249 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.16%
1/617 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/630 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/250 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/249 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
|
Cardiac disorders
Bradycardia
|
0.16%
1/617 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/630 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/250 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/249 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
|
Cardiac disorders
Cardiomyopathy
|
0.16%
1/617 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/630 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/250 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/249 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/617 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.16%
1/630 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/250 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/249 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/617 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.16%
1/630 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/250 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/249 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
|
Gastrointestinal disorders
Anal fistula
|
0.16%
1/617 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/630 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/250 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/249 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
|
General disorders
Chest pain
|
0.00%
0/617 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.16%
1/630 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/250 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/249 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
|
General disorders
Death
|
0.00%
0/617 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/630 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.40%
1/250 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/249 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
|
General disorders
Pyrexia
|
0.00%
0/617 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.16%
1/630 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/250 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/249 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
|
Infections and infestations
Abscess
|
1.3%
8/617 • Number of events 8 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.48%
3/630 • Number of events 3 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.40%
1/250 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.40%
1/249 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
1.2%
3/248 • Number of events 3 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
1.6%
4/248 • Number of events 4 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
|
Infections and infestations
Abscess limb
|
0.16%
1/617 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.16%
1/630 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/250 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/249 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.40%
1/248 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/617 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.16%
1/630 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/250 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/249 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
|
Infections and infestations
Breast abscess
|
0.16%
1/617 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/630 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/250 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/249 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
|
Infections and infestations
Bursitis infective
|
0.16%
1/617 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/630 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/250 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/249 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
|
Infections and infestations
Cellulitis
|
1.5%
9/617 • Number of events 9 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.79%
5/630 • Number of events 6 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
2.0%
5/250 • Number of events 5 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.40%
1/249 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
3.6%
9/248 • Number of events 10 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
4.4%
11/248 • Number of events 11 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
|
Infections and infestations
Cellulitis staphylococcal
|
0.00%
0/617 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/630 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/250 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.40%
1/249 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/617 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/630 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/250 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/249 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.40%
1/248 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
|
Infections and infestations
Coccidioidomycosis
|
0.00%
0/617 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.16%
1/630 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/250 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/249 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/617 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/630 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/250 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/249 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.40%
1/248 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/617 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.16%
1/630 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/250 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/249 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
|
Infections and infestations
Infection
|
0.00%
0/617 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/630 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.40%
1/250 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/249 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
|
Infections and infestations
Localised infection
|
0.16%
1/617 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/630 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/250 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/249 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
|
Infections and infestations
Necrotising fasciitis
|
0.00%
0/617 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/630 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/250 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/249 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.40%
1/248 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/617 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/630 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/250 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/249 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.40%
1/248 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
|
Infections and infestations
Periorbital cellulitis
|
0.00%
0/617 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/630 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/250 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/249 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.40%
1/248 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.40%
1/248 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/617 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.16%
1/630 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/250 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/249 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
|
Infections and infestations
Pyelonephritis
|
0.16%
1/617 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/630 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/250 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/249 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.40%
1/248 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
|
Infections and infestations
Sepsis
|
0.00%
0/617 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.16%
1/630 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/250 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/249 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
|
Infections and infestations
Skin infection
|
0.00%
0/617 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/630 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/250 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.40%
1/249 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
|
Infections and infestations
Viral infection
|
0.16%
1/617 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/630 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/250 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/249 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
|
Infections and infestations
Wound infection
|
0.00%
0/617 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/630 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
1.6%
4/250 • Number of events 4 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
1.2%
3/249 • Number of events 3 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
|
Injury, poisoning and procedural complications
Lip injury
|
0.16%
1/617 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/630 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/250 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/249 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.16%
1/617 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/630 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/250 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/249 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.40%
1/248 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/617 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/630 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/250 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.40%
1/249 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.16%
1/617 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/630 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/250 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/249 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.16%
1/617 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/630 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/250 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/249 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/617 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.16%
1/630 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/250 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/249 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.40%
1/248 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
|
Psychiatric disorders
Depression
|
0.00%
0/617 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/630 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.40%
1/250 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.40%
1/249 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
|
Psychiatric disorders
Drug dependence
|
0.00%
0/617 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/630 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/250 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.40%
1/249 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/617 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/630 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/250 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/249 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.40%
1/248 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/617 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.16%
1/630 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.40%
1/250 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.40%
1/249 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/617 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.16%
1/630 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/250 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/249 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/617 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/630 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/250 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/249 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.40%
1/248 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
|
Renal and urinary disorders
Renal failure acute
|
0.16%
1/617 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.16%
1/630 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.40%
1/250 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/249 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.40%
1/248 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.32%
2/617 • Number of events 2 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/630 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/250 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/249 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/617 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.16%
1/630 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/250 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/249 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.16%
1/617 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/630 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/250 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/249 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/617 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/630 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/250 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/249 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.40%
1/248 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/617 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/630 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/250 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/249 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.40%
1/248 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/248 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
|
Vascular disorders
Hypertension
|
0.00%
0/617 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/630 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/250 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.00%
0/249 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.40%
1/248 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.40%
1/248 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
Other adverse events
| Measure |
Abscess, Placebo
n=617 participants at risk
Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
|
Abscess, TMP/SMX
n=630 participants at risk
Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Infected Wound, TMP/SMX
n=250 participants at risk
Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
|
Infected Wound, Clindamycin
n=249 participants at risk
Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
|
Cellulitis, Cephalexin and TMP/SMX
n=248 participants at risk
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
|
Cellulitis, Cephalexin
n=248 participants at risk
Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.2%
26/617 • Number of events 27 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
6.0%
38/630 • Number of events 40 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
6.8%
17/250 • Number of events 17 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
6.0%
15/249 • Number of events 20 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
7.7%
19/248 • Number of events 20 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
4.4%
11/248 • Number of events 11 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
|
Infections and infestations
Abscess
|
21.1%
130/617 • Number of events 152 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
14.0%
88/630 • Number of events 100 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
8.0%
20/250 • Number of events 26 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
4.8%
12/249 • Number of events 13 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
10.9%
27/248 • Number of events 29 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
13.3%
33/248 • Number of events 39 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
|
Infections and infestations
Cellulitis
|
0.81%
5/617 • Number of events 5 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.79%
5/630 • Number of events 5 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
2.4%
6/250 • Number of events 6 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.80%
2/249 • Number of events 2 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
10.9%
27/248 • Number of events 29 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
11.3%
28/248 • Number of events 28 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
|
Gastrointestinal disorders
Constipation
|
2.6%
16/617 • Number of events 16 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
4.0%
25/630 • Number of events 25 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
6.8%
17/250 • Number of events 18 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.40%
1/249 • Number of events 1 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
2.8%
7/248 • Number of events 7 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
2.0%
5/248 • Number of events 5 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
|
Gastrointestinal disorders
Diarrhoea
|
15.6%
96/617 • Number of events 102 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
14.9%
94/630 • Number of events 103 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
17.2%
43/250 • Number of events 48 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
32.5%
81/249 • Number of events 90 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
21.8%
54/248 • Number of events 59 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
19.0%
47/248 • Number of events 52 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
|
Nervous system disorders
Dizziness
|
6.3%
39/617 • Number of events 41 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
6.5%
41/630 • Number of events 41 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
5.2%
13/250 • Number of events 14 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
5.2%
13/249 • Number of events 13 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
7.3%
18/248 • Number of events 20 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
6.5%
16/248 • Number of events 16 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
|
Nervous system disorders
Headache
|
12.3%
76/617 • Number of events 81 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
15.9%
100/630 • Number of events 112 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
13.6%
34/250 • Number of events 36 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
10.8%
27/249 • Number of events 29 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
16.5%
41/248 • Number of events 45 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
16.9%
42/248 • Number of events 43 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
|
Gastrointestinal disorders
Nausea
|
16.5%
102/617 • Number of events 112 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
21.3%
134/630 • Number of events 141 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
20.0%
50/250 • Number of events 56 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
11.2%
28/249 • Number of events 29 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
19.8%
49/248 • Number of events 51 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
16.5%
41/248 • Number of events 42 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
|
General disorders
Pyrexia
|
4.1%
25/617 • Number of events 26 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
2.7%
17/630 • Number of events 17 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
0.80%
2/250 • Number of events 2 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
1.2%
3/249 • Number of events 3 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
5.2%
13/248 • Number of events 13 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
6.0%
15/248 • Number of events 16 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.5%
9/617 • Number of events 9 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
2.5%
16/630 • Number of events 16 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
2.4%
6/250 • Number of events 6 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
1.6%
4/249 • Number of events 4 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
5.6%
14/248 • Number of events 14 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
2.0%
5/248 • Number of events 5 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
|
Gastrointestinal disorders
Vomiting
|
6.5%
40/617 • Number of events 42 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
10.0%
63/630 • Number of events 64 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
8.8%
22/250 • Number of events 24 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
5.6%
14/249 • Number of events 14 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
7.7%
19/248 • Number of events 19 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
7.7%
19/248 • Number of events 21 • All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60