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
|
|---|---|---|---|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
101 Participants
n=99 Participants
|
107 Participants
n=107 Participants
|
208 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
12 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
63 Participants
n=99 Participants
|
59 Participants
n=107 Participants
|
122 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
49 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
104 Participants
n=206 Participants
|
|
Age, Continuous
|
4.5 years
n=99 Participants
|
3.42 years
n=107 Participants
|
4.08 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
83 Participants
n=99 Participants
|
74 Participants
n=107 Participants
|
157 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
92 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
24 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Abscess location
Abscess below the waist
|
87 participants
n=99 Participants
|
91 participants
n=107 Participants
|
178 participants
n=206 Participants
|
|
Abscess location
Abscess above the waist
|
37 participants
n=99 Participants
|
30 participants
n=107 Participants
|
67 participants
n=206 Participants
|
|
Abscess location
Abscess both locations
|
1 participants
n=99 Participants
|
3 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
presence of fever
fever
|
11 participants
n=99 Participants
|
11 participants
n=107 Participants
|
22 participants
n=206 Participants
|
|
presence of fever
no fever
|
114 participants
n=99 Participants
|
113 participants
n=107 Participants
|
227 participants
n=206 Participants
|
|
presence of cellulitis
cellulitis
|
22 participants
n=99 Participants
|
38 participants
n=107 Participants
|
60 participants
n=206 Participants
|
|
presence of cellulitis
no cellulitis
|
103 participants
n=99 Participants
|
86 participants
n=107 Participants
|
189 participants
n=206 Participants
|
|
Clindamycin administered in ED
Yes
|
12 participants
n=99 Participants
|
29 participants
n=107 Participants
|
41 participants
n=206 Participants
|
|
Clindamycin administered in ED
No
|
113 participants
n=99 Participants
|
95 participants
n=107 Participants
|
208 participants
n=206 Participants
|
|
History of abscess
Yes
|
50 participants
n=99 Participants
|
42 participants
n=107 Participants
|
92 participants
n=206 Participants
|
|
History of abscess
No
|
75 participants
n=99 Participants
|
82 participants
n=107 Participants
|
157 participants
n=206 Participants
|
|
History of household contact with abscess
Yes
|
62 participants
n=99 Participants
|
63 participants
n=107 Participants
|
125 participants
n=206 Participants
|
|
History of household contact with abscess
No
|
63 participants
n=99 Participants
|
61 participants
n=107 Participants
|
124 participants
n=206 Participants
|
|
Presence of ≥ 2 Abscesses
Yes
|
11 participants
n=99 Participants
|
7 participants
n=107 Participants
|
18 participants
n=206 Participants
|
|
Presence of ≥ 2 Abscesses
No
|
114 participants
n=99 Participants
|
117 participants
n=107 Participants
|
231 participants
n=206 Participants
|
|
Abscess size
|
6.25 cm2
n=99 Participants
|
6.25 cm2
n=107 Participants
|
6.25 cm2
n=206 Participants
|
|
Culture results
MRSA
|
69 participants
n=99 Participants
|
69 participants
n=107 Participants
|
138 participants
n=206 Participants
|
|
Culture results
MSSA
|
39 participants
n=99 Participants
|
40 participants
n=107 Participants
|
79 participants
n=206 Participants
|
|
Culture results
Other
|
14 participants
n=99 Participants
|
14 participants
n=107 Participants
|
28 participants
n=206 Participants
|
|
Culture results
No Growth
|
3 participants
n=99 Participants
|
1 participants
n=107 Participants
|
4 participants
n=206 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