Trial Outcomes & Findings for Prospective Randomized Trial of Bactrim on 7 Day Outcome in Patients With Uncomplicated Abscesses (NCT NCT00973765)
NCT ID: NCT00973765
Last Updated: 2010-03-09
Results Overview
worsening abscess or new recurrence of abscess
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
212 participants
Primary outcome timeframe
7 days
Results posted on
2010-03-09
Participant Flow
July 1, 2008 - June 1, 2009 in emergency department
Participant milestones
| Measure |
Active Comparator
Bactrim DS (800/160) 2 pills po BID x 7 days
|
Placebo
Matched placebo 2 pills po BID x 7 days
|
|---|---|---|
|
Overall Study
STARTED
|
96
|
116
|
|
Overall Study
COMPLETED
|
88
|
102
|
|
Overall Study
NOT COMPLETED
|
8
|
14
|
Reasons for withdrawal
| Measure |
Active Comparator
Bactrim DS (800/160) 2 pills po BID x 7 days
|
Placebo
Matched placebo 2 pills po BID x 7 days
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
8
|
14
|
Baseline Characteristics
Prospective Randomized Trial of Bactrim on 7 Day Outcome in Patients With Uncomplicated Abscesses
Baseline characteristics by cohort
| Measure |
Active Comparator
n=96 Participants
Bactrim DS (800/160) 2 pills po BID x 7 days
|
Placebo
n=116 Participants
Matched placebo 2 pills po BID x 7 days
|
Total
n=212 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
94 Participants
n=99 Participants
|
116 Participants
n=107 Participants
|
210 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Age Continuous
|
31.5 years
STANDARD_DEVIATION 13.3 • n=99 Participants
|
31.1 years
STANDARD_DEVIATION 12.5 • n=107 Participants
|
31.3 years
STANDARD_DEVIATION 12.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
72 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
68 Participants
n=99 Participants
|
72 Participants
n=107 Participants
|
140 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
96 participants
n=99 Participants
|
116 participants
n=107 Participants
|
212 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 7 daysworsening abscess or new recurrence of abscess
Outcome measures
| Measure |
Active Comparator
n=96 Participants
Bactrim DS (800/160) 2 pills po BID x 7 days
|
Placebo
n=116 Participants
Matched placebo 2 pills po BID x 7 days
|
|---|---|---|
|
Treatment Failures at 7 Days
|
15 participants
|
27 participants
|
Adverse Events
Active Comparator
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
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