Trial Outcomes & Findings for Uncomplicated Skin and Soft Tissue Infections Caused by Community-Associated Methicillin-Resistant Staphylococcus Aureus (NCT NCT00730028)
NCT ID: NCT00730028
Last Updated: 2016-03-17
Results Overview
Clinical failure is defined as the occurence of any of the following: 1. Lack of resolution at the Test of Cure (TOC) visit in any or all of the following: erythema, tenderness, purulent drainage, swelling, and local warmth. Erythema or tenderness that was considered due the surgical therapy itself (incision and drainage), was not considered to be indicative of clinical failure. 2. Occurrence of a SSTI at another site other than the site(s) under study. 3. Intolerance of study medication or a treatment-limiting adverse reaction necessitating discontinuation of study drug within the first 48 hours. 4. Administration of other antimicrobial therapy for treatment of a SSTI at any time through the TOC visit. 5. Unplanned surgical procedure for the infection under study at any time through the TOC visit. 6. Hospitalization for treatment of active or invasive infection at any time through the TOC visit.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
1310 participants
Primary outcome timeframe
Test of cure (TOC) (7-10 days after completion of therapy)
Results posted on
2016-03-17
Participant Flow
Participants were non-immunocompromised out-patients age 6 months to 85 years with SSTIs not requiring hospital admission were recruited across 6 sites from communities with an anticipated prevalence of community-associated MRSA. Participants were enrolled between April 13, 2009 and January 13, 2015
Participant milestones
| Measure |
Cellulitis or Larger Abscess - Clindamycin
Participants with cellulitis only or abscess \> 5 cm in diameter in adults and children age 9 years and older, \> 4 cm in diameter in children age 1 to 8 years, or \> 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
|
Cellulitis or Larger Abscess - TMP-SMX
Participants with cellulitis only or abscess \> 5 cm in diameter in adults and children age 9 years and older, \> 4 cm in diameter in children age 1 to 8 years, or \> 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
|
Limited Abscess - Clindamycin
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, \< 4 cm in diameter in children age 1 to 8 years, or \< 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
|
Limited Abscess - TMP-SMX
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, \< 4 cm in diameter in children age 1 to 8 years, or \< 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
|
Limited Abscess - Placebo
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, \< 4 cm in diameter in children age 1 to 8 years, or \< 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
264
|
260
|
266
|
263
|
257
|
|
Overall Study
COMPLETED
|
204
|
194
|
221
|
207
|
175
|
|
Overall Study
NOT COMPLETED
|
60
|
66
|
45
|
56
|
82
|
Reasons for withdrawal
| Measure |
Cellulitis or Larger Abscess - Clindamycin
Participants with cellulitis only or abscess \> 5 cm in diameter in adults and children age 9 years and older, \> 4 cm in diameter in children age 1 to 8 years, or \> 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
|
Cellulitis or Larger Abscess - TMP-SMX
Participants with cellulitis only or abscess \> 5 cm in diameter in adults and children age 9 years and older, \> 4 cm in diameter in children age 1 to 8 years, or \> 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
|
Limited Abscess - Clindamycin
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, \< 4 cm in diameter in children age 1 to 8 years, or \< 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
|
Limited Abscess - TMP-SMX
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, \< 4 cm in diameter in children age 1 to 8 years, or \< 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
|
Limited Abscess - Placebo
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, \< 4 cm in diameter in children age 1 to 8 years, or \< 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
23
|
26
|
16
|
20
|
43
|
|
Overall Study
Lost to Follow-up
|
13
|
26
|
22
|
26
|
25
|
|
Overall Study
Protocol Violation
|
6
|
1
|
1
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
9
|
5
|
4
|
5
|
9
|
|
Overall Study
Physician Decision
|
3
|
3
|
2
|
3
|
2
|
|
Overall Study
Treatment Failure
|
5
|
5
|
0
|
0
|
1
|
|
Overall Study
Randomization Error
|
1
|
0
|
0
|
0
|
2
|
Baseline Characteristics
Uncomplicated Skin and Soft Tissue Infections Caused by Community-Associated Methicillin-Resistant Staphylococcus Aureus
Baseline characteristics by cohort
| Measure |
Cellulitis or Larger Abscess - Clindamycin
n=264 Participants
Participants with cellulitis only or abscess \> 5 cm in diameter in adults and children age 9 years and older, \> 4 cm in diameter in children age 1 to 8 years, or \> 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
|
Cellulitis or Larger Abscess - TMP-SMX
n=260 Participants
Participants with cellulitis only or abscess \> 5 cm in diameter in adults and children age 9 years and older, \> 4 cm in diameter in children age 1 to 8 years, or \> 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
|
Limited Abscess - Clindamycin
n=266 Participants
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, \< 4 cm in diameter in children age 1 to 8 years, or \< 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
|
Limited Abscess - TMP-SMX
n=263 Participants
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, \< 4 cm in diameter in children age 1 to 8 years, or \< 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
|
Limited Abscess - Placebo
n=257 Participants
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, \< 4 cm in diameter in children age 1 to 8 years, or \< 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
|
Total
n=1310 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
81 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
91 Participants
n=4 Participants
|
89 Participants
n=21 Participants
|
436 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
181 Participants
n=5 Participants
|
184 Participants
n=7 Participants
|
164 Participants
n=5 Participants
|
169 Participants
n=4 Participants
|
166 Participants
n=21 Participants
|
864 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
|
Age, Continuous
|
26.8 years
STANDARD_DEVIATION 17.2 • n=5 Participants
|
27.5 years
STANDARD_DEVIATION 16.9 • n=7 Participants
|
24.8 years
STANDARD_DEVIATION 17.8 • n=5 Participants
|
25.6 years
STANDARD_DEVIATION 18.1 • n=4 Participants
|
26.2 years
STANDARD_DEVIATION 18.7 • n=21 Participants
|
27.1 years
STANDARD_DEVIATION 17.0 • n=8 Participants
|
|
Sex: Female, Male
Female
|
129 Participants
n=5 Participants
|
121 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
111 Participants
n=4 Participants
|
101 Participants
n=21 Participants
|
588 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
135 Participants
n=5 Participants
|
139 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
152 Participants
n=4 Participants
|
156 Participants
n=21 Participants
|
722 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
264 participants
n=5 Participants
|
260 participants
n=7 Participants
|
266 participants
n=5 Participants
|
263 participants
n=4 Participants
|
257 participants
n=21 Participants
|
1310 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Test of cure (TOC) (7-10 days after completion of therapy)Population: The efficacy evaluable population was comprised of all participants who had outcomes determined at the Test of Cure (TOC) visit.
Clinical failure is defined as the occurence of any of the following: 1. Lack of resolution at the Test of Cure (TOC) visit in any or all of the following: erythema, tenderness, purulent drainage, swelling, and local warmth. Erythema or tenderness that was considered due the surgical therapy itself (incision and drainage), was not considered to be indicative of clinical failure. 2. Occurrence of a SSTI at another site other than the site(s) under study. 3. Intolerance of study medication or a treatment-limiting adverse reaction necessitating discontinuation of study drug within the first 48 hours. 4. Administration of other antimicrobial therapy for treatment of a SSTI at any time through the TOC visit. 5. Unplanned surgical procedure for the infection under study at any time through the TOC visit. 6. Hospitalization for treatment of active or invasive infection at any time through the TOC visit.
Outcome measures
| Measure |
Cellulitis or Larger Abscess - Clindamycin
n=237 Participants
Participants with cellulitis only or abscess \> 5 cm in diameter in adults and children age 9 years and older, \> 4 cm in diameter in children age 1 to 8 years, or \> 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
|
Cellulitis or Larger Abscess - TMP-SMX
n=229 Participants
Participants with cellulitis only or abscess \> 5 cm in diameter in adults and children age 9 years and older, \> 4 cm in diameter in children age 1 to 8 years, or \> 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
|
Limited Abscess - Clindamycin
n=238 Participants
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, \< 4 cm in diameter in children age 1 to 8 years, or \< 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
|
Limited Abscess - TMP-SMX
n=232 Participants
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, \< 4 cm in diameter in children age 1 to 8 years, or \< 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
|
Limited Abscess - Placebo
n=220 Participants
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, \< 4 cm in diameter in children age 1 to 8 years, or \< 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving Clinical Cure, Defined as Absence of Clinical Failure, in the Evaluable Population.
|
89.5 percentage of participants
Interval 85.2 to 93.7
|
88.2 percentage of participants
Interval 83.7 to 92.7
|
92.9 percentage of participants
Interval 89.3 to 96.4
|
92.7 percentage of participants
Interval 89.0 to 96.3
|
80.5 percentage of participants
Interval 74.8 to 86.1
|
PRIMARY outcome
Timeframe: Test of cure (TOC) (7-10 days after completion of therapy)Population: The ITT population was comprised of all participants enrolled in the trial.
Clinical failure is defined as the occurence of any of the following: 1. Lack of resolution at the Test of Cure (TOC) visit in any or all of the following: erythema, tenderness, purulent drainage, swelling, and local warmth. Erythema or tenderness that was considered due the surgical therapy itself (incision and drainage), was not considered to be indicative of clinical failure. 2. Occurrence of a SSTI at another site other than the site(s) under study. 3. Intolerance of study medication or a treatment-limiting adverse reaction necessitating discontinuation of study drug within the first 48 hours. 4. Administration of other antimicrobial therapy for treatment of a SSTI at any time through the TOC visit. 5. Unplanned surgical procedure for the infection under study at any time through the TOC visit. 6. Hospitalization for treatment of active or invasive infection at any time through the TOC visit.
Outcome measures
| Measure |
Cellulitis or Larger Abscess - Clindamycin
n=264 Participants
Participants with cellulitis only or abscess \> 5 cm in diameter in adults and children age 9 years and older, \> 4 cm in diameter in children age 1 to 8 years, or \> 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
|
Cellulitis or Larger Abscess - TMP-SMX
n=260 Participants
Participants with cellulitis only or abscess \> 5 cm in diameter in adults and children age 9 years and older, \> 4 cm in diameter in children age 1 to 8 years, or \> 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
|
Limited Abscess - Clindamycin
n=266 Participants
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, \< 4 cm in diameter in children age 1 to 8 years, or \< 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
|
Limited Abscess - TMP-SMX
n=263 Participants
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, \< 4 cm in diameter in children age 1 to 8 years, or \< 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
|
Limited Abscess - Placebo
n=257 Participants
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, \< 4 cm in diameter in children age 1 to 8 years, or \< 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving Clinical Cure, Defined as Absence of Clinical Failure, in the Intent-to-Treat (ITT) Population.
|
80.3 percentage of participants
Interval 75.2 to 85.4
|
77.7 percentage of participants
Interval 72.3 to 83.1
|
83.1 percentage of participants
Interval 78.3 to 87.9
|
81.7 percentage of participants
Interval 76.8 to 86.7
|
68.9 percentage of participants
Interval 62.9 to 74.9
|
SECONDARY outcome
Timeframe: End of Treatment (EOT) (48 hours after completion of therapy); Test of Cure (TOC) (7-10 days after completion of therapy); One Month Follow-up Visit (OMFU)Population: Participants who received treatment with either clindamycin or TMP/SMX in the cellulitis or larger abscess group and participants who received treatment with either clindamycin, TMP/SMX, or placebo in the limited abscess group.
Subjects were issued a Memory Aid to record symptoms for 10 days post product administration. At study visits, the staff reviewed the memory aid and elicited as much information as possible about any reported symptoms. Occurrence of adverse events was solicited in the memory aid and during study visits. Reported symptoms, both solicited and unsolicited, were recorded as Adverse Events.
Outcome measures
| Measure |
Cellulitis or Larger Abscess - Clindamycin
n=259 Participants
Participants with cellulitis only or abscess \> 5 cm in diameter in adults and children age 9 years and older, \> 4 cm in diameter in children age 1 to 8 years, or \> 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
|
Cellulitis or Larger Abscess - TMP-SMX
n=258 Participants
Participants with cellulitis only or abscess \> 5 cm in diameter in adults and children age 9 years and older, \> 4 cm in diameter in children age 1 to 8 years, or \> 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
|
Limited Abscess - Clindamycin
n=265 Participants
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, \< 4 cm in diameter in children age 1 to 8 years, or \< 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
|
Limited Abscess - TMP-SMX
n=261 Participants
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, \< 4 cm in diameter in children age 1 to 8 years, or \< 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
|
Limited Abscess - Placebo
n=255 Participants
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, \< 4 cm in diameter in children age 1 to 8 years, or \< 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
|
|---|---|---|---|---|---|
|
Number of Participants Reporting Adverse Events.
|
116 participants
|
132 participants
|
119 participants
|
94 participants
|
119 participants
|
SECONDARY outcome
Timeframe: End of Treatment (EOT) (48 hours after completion of therapy); Test of Cure (TOC) (7-10 days after completion of therapy); One Month Follow-up Visit (OMFU)Population: Participants who received treatment with either clindamycin or TMP/SMX in the cellulitis or larger abscess group and participants who received treatment with either clindamycin, TMP/SMX, or placebo in the limited abscess group.
Participants were issued a Memory Aid to record symptoms for 10 days post product administration. At study visits, the staff reviewed the memory aid and elicited as much information as possible about any reported symptoms. Occurrence of adverse events was solicited in the memory aid and during study visits. Reported symptoms, both solicited and unsolicited, were recorded as Adverse Events. For these results, adverse events that resulted in discontinuation of study treatment for the participant were considered treatment limiting.
Outcome measures
| Measure |
Cellulitis or Larger Abscess - Clindamycin
n=259 Participants
Participants with cellulitis only or abscess \> 5 cm in diameter in adults and children age 9 years and older, \> 4 cm in diameter in children age 1 to 8 years, or \> 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
|
Cellulitis or Larger Abscess - TMP-SMX
n=258 Participants
Participants with cellulitis only or abscess \> 5 cm in diameter in adults and children age 9 years and older, \> 4 cm in diameter in children age 1 to 8 years, or \> 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
|
Limited Abscess - Clindamycin
n=265 Participants
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, \< 4 cm in diameter in children age 1 to 8 years, or \< 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
|
Limited Abscess - TMP-SMX
n=261 Participants
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, \< 4 cm in diameter in children age 1 to 8 years, or \< 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
|
Limited Abscess - Placebo
n=255 Participants
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, \< 4 cm in diameter in children age 1 to 8 years, or \< 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
|
|---|---|---|---|---|---|
|
Number of Participants Reporting Adverse Events That Are Treatment Limiting.
|
1 participants
|
0 participants
|
6 participants
|
3 participants
|
4 participants
|
SECONDARY outcome
Timeframe: EOT visit within 48 hours of completion of therapyPopulation: The efficacy evaluable population was comprised of all participants who had outcomes determined at the EOT visit.
Measures of clinical cure and clinical failure are the same as those defined for the primary efficacy outcome measure.
Outcome measures
| Measure |
Cellulitis or Larger Abscess - Clindamycin
n=240 Participants
Participants with cellulitis only or abscess \> 5 cm in diameter in adults and children age 9 years and older, \> 4 cm in diameter in children age 1 to 8 years, or \> 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
|
Cellulitis or Larger Abscess - TMP-SMX
n=222 Participants
Participants with cellulitis only or abscess \> 5 cm in diameter in adults and children age 9 years and older, \> 4 cm in diameter in children age 1 to 8 years, or \> 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
|
Limited Abscess - Clindamycin
n=231 Participants
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, \< 4 cm in diameter in children age 1 to 8 years, or \< 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
|
Limited Abscess - TMP-SMX
n=223 Participants
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, \< 4 cm in diameter in children age 1 to 8 years, or \< 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
|
Limited Abscess - Placebo
n=219 Participants
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, \< 4 cm in diameter in children age 1 to 8 years, or \< 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving Clinical Cure at the End of Treatment (EOT) Visit for the Evaluable Population.
|
89.2 percentage of participants
Interval 85.0 to 93.3
|
88.3 percentage of participants
Interval 83.8 to 92.7
|
90.9 percentage of participants
Interval 87.0 to 94.8
|
94.2 percentage of participants
Interval 90.9 to 97.5
|
84.9 percentage of participants
Interval 80.0 to 89.9
|
SECONDARY outcome
Timeframe: EOT visit within 48 hours of completion of therapyPopulation: All participants enrolled in the trial.
Measures of clinical cure and clinical failure are the same as those defined for the primary efficacy outcome measure.
Outcome measures
| Measure |
Cellulitis or Larger Abscess - Clindamycin
n=264 Participants
Participants with cellulitis only or abscess \> 5 cm in diameter in adults and children age 9 years and older, \> 4 cm in diameter in children age 1 to 8 years, or \> 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
|
Cellulitis or Larger Abscess - TMP-SMX
n=260 Participants
Participants with cellulitis only or abscess \> 5 cm in diameter in adults and children age 9 years and older, \> 4 cm in diameter in children age 1 to 8 years, or \> 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
|
Limited Abscess - Clindamycin
n=266 Participants
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, \< 4 cm in diameter in children age 1 to 8 years, or \< 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
|
Limited Abscess - TMP-SMX
n=263 Participants
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, \< 4 cm in diameter in children age 1 to 8 years, or \< 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
|
Limited Abscess - Placebo
n=257 Participants
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, \< 4 cm in diameter in children age 1 to 8 years, or \< 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving Clinical Cure at the End of Treatment (EOT) Visit for the Intent-to-Treat (ITT) Population.
|
81.1 percentage of participants
Interval 76.1 to 86.0
|
75.4 percentage of participants
Interval 70.0 to 80.8
|
78.9 percentage of participants
Interval 73.9 to 84.0
|
79.8 percentage of participants
Interval 74.8 to 84.9
|
72.4 percentage of participants
Interval 66.7 to 78.0
|
SECONDARY outcome
Timeframe: OMFU visitPopulation: The efficacy evaluable population was comprised of all participants who had outcomes determined at the OMFU visit.
Measures of clinical cure and clinical failure are the same as those defined for the primary efficacy outcome measure, with one addition. At the OMFU, relapse (the return of the original infection after initial improvement) or recurrence (return of skin infection at original site after cure of original infection) of SSTI was scored as clinical failure.
Outcome measures
| Measure |
Cellulitis or Larger Abscess - Clindamycin
n=230 Participants
Participants with cellulitis only or abscess \> 5 cm in diameter in adults and children age 9 years and older, \> 4 cm in diameter in children age 1 to 8 years, or \> 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
|
Cellulitis or Larger Abscess - TMP-SMX
n=225 Participants
Participants with cellulitis only or abscess \> 5 cm in diameter in adults and children age 9 years and older, \> 4 cm in diameter in children age 1 to 8 years, or \> 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
|
Limited Abscess - Clindamycin
n=234 Participants
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, \< 4 cm in diameter in children age 1 to 8 years, or \< 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
|
Limited Abscess - TMP-SMX
n=226 Participants
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, \< 4 cm in diameter in children age 1 to 8 years, or \< 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
|
Limited Abscess - Placebo
n=218 Participants
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, \< 4 cm in diameter in children age 1 to 8 years, or \< 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving Clinical Cure at the One Month Follow-up (OMFU) Visit for the Evaluable Population.
|
83.9 percentage of participants
Interval 78.9 to 88.9
|
78.2 percentage of participants
Interval 72.6 to 83.8
|
89.3 percentage of participants
Interval 85.1 to 93.5
|
85.0 percentage of participants
Interval 80.1 to 89.8
|
73.9 percentage of participants
Interval 67.8 to 79.9
|
SECONDARY outcome
Timeframe: OMFU visitPopulation: All participants enrolled in the trial.
Measures of clinical cure and clinical failure are the same as those defined for the primary efficacy outcome measure, with one addition. At the OMFU, relapse (the return of the original infection after initial improvement) or recurrence (return of skin infection at original site after cure of original infection) of SSTI was scored as clinical failure.
Outcome measures
| Measure |
Cellulitis or Larger Abscess - Clindamycin
n=264 Participants
Participants with cellulitis only or abscess \> 5 cm in diameter in adults and children age 9 years and older, \> 4 cm in diameter in children age 1 to 8 years, or \> 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
|
Cellulitis or Larger Abscess - TMP-SMX
n=260 Participants
Participants with cellulitis only or abscess \> 5 cm in diameter in adults and children age 9 years and older, \> 4 cm in diameter in children age 1 to 8 years, or \> 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
|
Limited Abscess - Clindamycin
n=266 Participants
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, \< 4 cm in diameter in children age 1 to 8 years, or \< 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
|
Limited Abscess - TMP-SMX
n=263 Participants
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, \< 4 cm in diameter in children age 1 to 8 years, or \< 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
|
Limited Abscess - Placebo
n=257 Participants
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, \< 4 cm in diameter in children age 1 to 8 years, or \< 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving Clinical Cure at the One Month Follow-up (OMFU) Visit for the Intent-to-Treat (ITT) Population.
|
73.1 percentage of participants
Interval 67.6 to 78.6
|
67.7 percentage of participants
Interval 61.8 to 73.6
|
78.6 percentage of participants
Interval 73.5 to 83.7
|
73.0 percentage of participants
Interval 67.4 to 78.6
|
62.6 percentage of participants
Interval 56.5 to 68.8
|
Adverse Events
Cellulitis or Larger Abscess - Clindamycin
Serious events: 4 serious events
Other events: 59 other events
Deaths: 0 deaths
Cellulitis or Larger Abscess - TMP-SMX
Serious events: 5 serious events
Other events: 72 other events
Deaths: 0 deaths
Limited Abscess - Clindamycin
Serious events: 0 serious events
Other events: 61 other events
Deaths: 0 deaths
Limited Abscess - TMP-SMX
Serious events: 6 serious events
Other events: 52 other events
Deaths: 0 deaths
Limited Abscess - Placebo
Serious events: 2 serious events
Other events: 60 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cellulitis or Larger Abscess - Clindamycin
n=264 participants at risk
Participants with cellulitis only or abscess \> 5 cm in diameter, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
|
Cellulitis or Larger Abscess - TMP-SMX
n=260 participants at risk
Participants with cellulitis only or abscess \> 5 cm in diameter, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
|
Limited Abscess - Clindamycin
n=266 participants at risk
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
|
Limited Abscess - TMP-SMX
n=263 participants at risk
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
|
Limited Abscess - Placebo
n=257 participants at risk
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter were treated with placebo three times daily.
|
|---|---|---|---|---|---|
|
Infections and infestations
Cellulitis
|
0.38%
1/264 • Number of events 1 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
0.77%
2/260 • Number of events 2 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
0.00%
0/266 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
0.38%
1/263 • Number of events 1 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
0.00%
0/257 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
|
Infections and infestations
Abscess
|
0.38%
1/264 • Number of events 1 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
0.00%
0/260 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
0.00%
0/266 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
0.76%
2/263 • Number of events 2 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
0.00%
0/257 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
|
Infections and infestations
Perirectal Abscess
|
0.38%
1/264 • Number of events 1 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
0.00%
0/260 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
0.00%
0/266 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
0.00%
0/263 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
0.39%
1/257 • Number of events 1 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
0.38%
1/264 • Number of events 1 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
0.00%
0/260 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
0.00%
0/266 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
0.00%
0/263 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
0.00%
0/257 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
|
Psychiatric disorders
Mental Disorder
|
0.00%
0/264 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
0.38%
1/260 • Number of events 1 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
0.00%
0/266 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
0.00%
0/263 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
0.00%
0/257 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
|
Gastrointestinal disorders
Crohn's Disease
|
0.00%
0/264 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
0.38%
1/260 • Number of events 1 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
0.00%
0/266 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
0.00%
0/263 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
0.00%
0/257 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
|
General disorders
Induration
|
0.00%
0/264 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
0.38%
1/260 • Number of events 1 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
0.00%
0/266 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
0.00%
0/263 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
0.00%
0/257 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/264 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
0.00%
0/260 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
0.00%
0/266 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
0.38%
1/263 • Number of events 1 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
0.00%
0/257 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
|
Skin and subcutaneous tissue disorders
Drug Eruption
|
0.00%
0/264 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
0.00%
0/260 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
0.00%
0/266 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
0.38%
1/263 • Number of events 1 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
0.00%
0/257 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
|
Respiratory, thoracic and mediastinal disorders
Status Asthmaticus
|
0.00%
0/264 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
0.00%
0/260 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
0.00%
0/266 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
0.38%
1/263 • Number of events 1 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
0.00%
0/257 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/264 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
0.00%
0/260 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
0.00%
0/266 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
0.00%
0/263 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
0.39%
1/257 • Number of events 1 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/264 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
0.00%
0/260 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
0.00%
0/266 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
0.00%
0/263 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
0.39%
1/257 • Number of events 1 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
Other adverse events
| Measure |
Cellulitis or Larger Abscess - Clindamycin
n=264 participants at risk
Participants with cellulitis only or abscess \> 5 cm in diameter, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
|
Cellulitis or Larger Abscess - TMP-SMX
n=260 participants at risk
Participants with cellulitis only or abscess \> 5 cm in diameter, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
|
Limited Abscess - Clindamycin
n=266 participants at risk
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
|
Limited Abscess - TMP-SMX
n=263 participants at risk
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
|
Limited Abscess - Placebo
n=257 participants at risk
Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter were treated with placebo three times daily.
|
|---|---|---|---|---|---|
|
Infections and infestations
Abscess
|
8.0%
21/264 • Number of events 23 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
15.0%
39/260 • Number of events 43 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
4.9%
13/266 • Number of events 13 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
11.0%
29/263 • Number of events 30 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
13.6%
35/257 • Number of events 36 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
|
Infections and infestations
Cellulitis
|
6.1%
16/264 • Number of events 19 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
8.8%
23/260 • Number of events 26 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
1.1%
3/266 • Number of events 3 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
2.3%
6/263 • Number of events 6 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
3.5%
9/257 • Number of events 12 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
|
Gastrointestinal disorders
Diarrhoea
|
10.2%
27/264 • Number of events 30 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
10.8%
28/260 • Number of events 29 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
17.3%
46/266 • Number of events 48 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
6.5%
17/263 • Number of events 19 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
7.8%
20/257 • Number of events 20 • Adverse events and serious adverse events were collected after administration of the first dose of study drug throughout the duration of the follow-up period (35-45 days after enrollment).
|
Additional Information
Henry F. Chambers, MD
San Francisco General Hospital, UCSF
Phone: (415) 206 - 5437
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60