Trial Outcomes & Findings for Evaluation of 3 Versus 10 Days of Antibiotics in Skin Abscesses After Surgical Drainage (NCT NCT02024867)
NCT ID: NCT02024867
Last Updated: 2015-10-19
Results Overview
Treatment failures were defined as persistent or increased size of the original abscess requiring further medical or surgical intervention. Treatment cure was defined as no or minimal tenderness, erythema, fever, wound drainage, warmth, fluctuance or induration at the 10 to 14 day follow-up.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
249 participants
Primary outcome timeframe
up to 2 weeks after surgical drainage
Results posted on
2015-10-19
Participant Flow
Participant milestones
| Measure |
3 Days
Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
|
10 Days
Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
|
|---|---|---|
|
Overall Study
STARTED
|
134
|
131
|
|
Overall Study
COMPLETED
|
125
|
124
|
|
Overall Study
NOT COMPLETED
|
9
|
7
|
Reasons for withdrawal
| Measure |
3 Days
Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
|
10 Days
Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
|
|---|---|---|
|
Overall Study
Protocol Violation
|
3
|
3
|
|
Overall Study
Lost to Follow-up
|
6
|
4
|
Baseline Characteristics
Evaluation of 3 Versus 10 Days of Antibiotics in Skin Abscesses After Surgical Drainage
Baseline characteristics by cohort
| Measure |
3 Days
n=125 Participants
Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
|
10 Days
n=124 Participants
Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
|
Total
n=249 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
4.5 years
n=5 Participants
|
3.42 years
n=7 Participants
|
4.08 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
83 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
157 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
24 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
101 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
208 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
63 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
49 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Abscess location
Abscess below the waist
|
87 participants
n=5 Participants
|
91 participants
n=7 Participants
|
178 participants
n=5 Participants
|
|
Abscess location
Abscess above the waist
|
37 participants
n=5 Participants
|
30 participants
n=7 Participants
|
67 participants
n=5 Participants
|
|
Abscess location
Abscess both locations
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
presence of fever
fever
|
11 participants
n=5 Participants
|
11 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
presence of fever
no fever
|
114 participants
n=5 Participants
|
113 participants
n=7 Participants
|
227 participants
n=5 Participants
|
|
presence of cellulitis
cellulitis
|
22 participants
n=5 Participants
|
38 participants
n=7 Participants
|
60 participants
n=5 Participants
|
|
presence of cellulitis
no cellulitis
|
103 participants
n=5 Participants
|
86 participants
n=7 Participants
|
189 participants
n=5 Participants
|
|
Clindamycin administered in ED
Yes
|
12 participants
n=5 Participants
|
29 participants
n=7 Participants
|
41 participants
n=5 Participants
|
|
Clindamycin administered in ED
No
|
113 participants
n=5 Participants
|
95 participants
n=7 Participants
|
208 participants
n=5 Participants
|
|
History of abscess
Yes
|
50 participants
n=5 Participants
|
42 participants
n=7 Participants
|
92 participants
n=5 Participants
|
|
History of abscess
No
|
75 participants
n=5 Participants
|
82 participants
n=7 Participants
|
157 participants
n=5 Participants
|
|
History of household contact with abscess
Yes
|
62 participants
n=5 Participants
|
63 participants
n=7 Participants
|
125 participants
n=5 Participants
|
|
History of household contact with abscess
No
|
63 participants
n=5 Participants
|
61 participants
n=7 Participants
|
124 participants
n=5 Participants
|
|
Presence of ≥ 2 Abscesses
Yes
|
11 participants
n=5 Participants
|
7 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Presence of ≥ 2 Abscesses
No
|
114 participants
n=5 Participants
|
117 participants
n=7 Participants
|
231 participants
n=5 Participants
|
|
Abscess size
|
6.25 cm2
n=5 Participants
|
6.25 cm2
n=7 Participants
|
6.25 cm2
n=5 Participants
|
|
Culture results
MRSA
|
69 participants
n=5 Participants
|
69 participants
n=7 Participants
|
138 participants
n=5 Participants
|
|
Culture results
MSSA
|
39 participants
n=5 Participants
|
40 participants
n=7 Participants
|
79 participants
n=5 Participants
|
|
Culture results
Other
|
14 participants
n=5 Participants
|
14 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Culture results
No Growth
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 2 weeks after surgical drainageTreatment failures were defined as persistent or increased size of the original abscess requiring further medical or surgical intervention. Treatment cure was defined as no or minimal tenderness, erythema, fever, wound drainage, warmth, fluctuance or induration at the 10 to 14 day follow-up.
Outcome measures
| Measure |
3 Days
n=125 Participants
Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
|
10 Days
n=124 Participants
Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
|
|---|---|---|
|
Treatment Failures
|
9 participants
|
4 participants
|
PRIMARY outcome
Timeframe: up to 2 weeks after surgical drainageTreatment failures were defined as persistent or increased size of the original abscess requiring further medical or surgical intervention. Treatment cure was defined as no or minimal tenderness, erythema, fever, wound drainage, warmth, fluctuance or induration at the 10 to 14 day follow-up.
Outcome measures
| Measure |
3 Days
n=69 Participants
Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
|
10 Days
n=69 Participants
Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
|
|---|---|---|
|
Treatment Failures Among Patients Infected With Methicillin-Resistant Staphylococcus Aureus
|
8 participants
|
1 participants
|
PRIMARY outcome
Timeframe: up to 2 weeks after surgical drainageTreatment failures were defined as persistent or increased size of the original abscess requiring further medical or surgical intervention. Treatment cure was defined as no or minimal tenderness, erythema, fever, wound drainage, warmth, fluctuance or induration at the 10 to 14 day follow-up.
Outcome measures
| Measure |
3 Days
n=39 Participants
Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
|
10 Days
n=40 Participants
Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
|
|---|---|---|
|
Treatment Failures Among Patients Infected With Methicillin-Sensitive Staphylococcus Aureus
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 1 month after surgical drainageRate of recurrent skin infection among follow-up responders 1 month after enrollment. Patients who were treatment failures were excluded from this analysis since they all received additional medical intervention that could affect the outcome measure.
Outcome measures
| Measure |
3 Days
n=115 Participants
Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
|
10 Days
n=118 Participants
Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
|
|---|---|---|
|
Recurrent Skin Infections
|
21 participants
|
9 participants
|
SECONDARY outcome
Timeframe: 1 month after surgical drainageRate of recurrent skin infection among follow-up responders 1 month after enrollment. Patients who were treatment failures were excluded from this analysis since they all received additional medical intervention that could affect the outcome measure.
Outcome measures
| Measure |
3 Days
n=60 Participants
Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
|
10 Days
n=67 Participants
Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
|
|---|---|---|
|
Recurrent Skin Infections Among Patients Infected With Methicillin-Resistant Staphylococcus Aureus
|
8 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 1 month after surgical drainageRate of recurrent skin infection among follow-up responders 1 month after enrollment. Patients who were treatment failures were excluded from this analysis since they all received additional medical intervention that could affect the outcome measure.
Outcome measures
| Measure |
3 Days
n=38 Participants
Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
|
10 Days
n=38 Participants
Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
|
|---|---|---|
|
Recurrent Skin Infections Among Patients Infected With Methicillin-Sensitive Staphylococcus Aureus
|
7 participants
|
7 participants
|
Adverse Events
3 Days
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
10 Days
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place