Trial Outcomes & Findings for Utility of Trimethoprim-sulfamethoxazole Use in Skin Abscess Management (NCT NCT00679302)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

161 participants

Primary outcome timeframe

10-14 days

Results posted on

2018-05-04

Participant Flow

Patients \>3months and \<18 years old with skin abscesses who are not immunocompromised, or in 3rd trimester of pregnancy were approached to participate in the study, or allergic to trimethoprim/sulfamethoxazole.

Enrolled participants were only excluded from the trial before assignment to groups if they left the emergency department prior to receiving the medication/placebo and further instructions.

Participant milestones

Participant milestones
Measure	Placebo Group Maalox and bitter mixture	Antibiotic Group Trimethoprim-sulfamethoxazole suspension
Overall Study STARTED	84	77
Overall Study COMPLETED	76	73
Overall Study NOT COMPLETED	8	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Group Maalox and bitter mixture	Antibiotic Group Trimethoprim-sulfamethoxazole suspension
Overall Study Lost to Follow-up	8	4

Baseline Characteristics

Utility of Trimethoprim-sulfamethoxazole Use in Skin Abscess Management

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo Group n=84 Participants Maalox and bitter mixture	Antibiotic Group n=77 Participants Trimethoprim-sulfamethoxazole suspension	Total n=161 Participants Total of all reporting groups
Age, Categorical <=18 years	84 Participants n=99 Participants	77 Participants n=107 Participants	161 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Continuous	4.5 years STANDARD_DEVIATION 0.5 • n=99 Participants	4.5 years STANDARD_DEVIATION 0.5 • n=107 Participants	4.5 years STANDARD_DEVIATION 0.5 • n=206 Participants
Sex: Female, Male Female	38 Participants n=99 Participants	30 Participants n=107 Participants	68 Participants n=206 Participants
Sex: Female, Male Male	46 Participants n=99 Participants	47 Participants n=107 Participants	93 Participants n=206 Participants
Region of Enrollment United States	84 participants n=99 Participants	77 participants n=107 Participants	161 participants n=206 Participants

PRIMARY outcome

Timeframe: 10-14 days

Outcome measures

Outcome measures
Measure	Placebo Group n=76 Participants Maalox and bitter mixture	Antibiotic Group n=73 Participants Trimethoprim-sulfamethoxazole suspension
Skin Abscess Resolution	4 participants Interval 1.2 to 6.8	3 participants Interval 1.2 to 6.8

SECONDARY outcome

Timeframe: 10-14 days and 3 month

The secondary outcomes of interest included the development of new lesions at a different site (\>5cm away from original skin abscess) on day 10 clinical follow-up or self-report and 3 month telephone follow-up.

Outcome measures

Outcome measures
Measure	Placebo Group n=52 Participants Maalox and bitter mixture	Antibiotic Group n=46 Participants Trimethoprim-sulfamethoxazole suspension
New Lesion Development and Spread of Skin Abscesses (on Subject)	15 participants	13 participants

Adverse Events

Placebo Group

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Antibiotic Group

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo Group n=76 participants at risk Maalox and bitter mixture	Antibiotic Group n=73 participants at risk Trimethoprim-sulfamethoxazole suspension
Skin and subcutaneous tissue disorders rash	0.00% 0/76 Participants were called 2-3 days later to set up follow up at day 10-14 and enquiries are made regarding any medication side effects. Phone calls were made 3 months later for further follow ups on recurrences and if other family members had developed skin abscesses.	4.1% 3/73 • Number of events 3 Participants were called 2-3 days later to set up follow up at day 10-14 and enquiries are made regarding any medication side effects. Phone calls were made 3 months later for further follow ups on recurrences and if other family members had developed skin abscesses.
Gastrointestinal disorders diarrhea	5.3% 4/76 • Number of events 4 Participants were called 2-3 days later to set up follow up at day 10-14 and enquiries are made regarding any medication side effects. Phone calls were made 3 months later for further follow ups on recurrences and if other family members had developed skin abscesses.	4.1% 3/73 • Number of events 3 Participants were called 2-3 days later to set up follow up at day 10-14 and enquiries are made regarding any medication side effects. Phone calls were made 3 months later for further follow ups on recurrences and if other family members had developed skin abscesses.
Gastrointestinal disorders vomiting	1.3% 1/76 • Number of events 1 Participants were called 2-3 days later to set up follow up at day 10-14 and enquiries are made regarding any medication side effects. Phone calls were made 3 months later for further follow ups on recurrences and if other family members had developed skin abscesses.	1.4% 1/73 • Number of events 1 Participants were called 2-3 days later to set up follow up at day 10-14 and enquiries are made regarding any medication side effects. Phone calls were made 3 months later for further follow ups on recurrences and if other family members had developed skin abscesses.
Gastrointestinal disorders vomiting and diarrhea	1.3% 1/76 • Number of events 1 Participants were called 2-3 days later to set up follow up at day 10-14 and enquiries are made regarding any medication side effects. Phone calls were made 3 months later for further follow ups on recurrences and if other family members had developed skin abscesses.	1.4% 1/73 • Number of events 1 Participants were called 2-3 days later to set up follow up at day 10-14 and enquiries are made regarding any medication side effects. Phone calls were made 3 months later for further follow ups on recurrences and if other family members had developed skin abscesses.
General disorders bad taste	1.3% 1/76 • Number of events 1 Participants were called 2-3 days later to set up follow up at day 10-14 and enquiries are made regarding any medication side effects. Phone calls were made 3 months later for further follow ups on recurrences and if other family members had developed skin abscesses.	6.8% 5/73 • Number of events 5 Participants were called 2-3 days later to set up follow up at day 10-14 and enquiries are made regarding any medication side effects. Phone calls were made 3 months later for further follow ups on recurrences and if other family members had developed skin abscesses.

Additional Information

Dr. Myto Duong, Pediatric Emergency Medicine Director

Southern Illinois University, School of Medicine

Phone: 217-545-7409

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place