Trial Outcomes & Findings for Antibiotics Versus Placebo in the Treatment of Abscesses in the Emergency Department (NCT NCT00867789)

Results Overview

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

140 participants

Primary outcome timeframe

two years

Results posted on

2021-01-26

Participant milestones
Measure	Trimethoprim-sulfamethaxazole Incision and drainage of the abscess and treatment with oral TMP-SMX (100 patients) Trimethoprim-sulfamethoxazole: 10mg/kg/day (based on trimethoprim component), divided twice daily for ten days (maximum dose: 160mg (TMP component) per dose)	Sugar Pill Incision and drainage of the abscess and treatment with oral placebo (100 patients) Sugar pill: 10mg/kg/day divided twice daily for ten days. Placebo liquid will contain simple syrup, lactose powder, grape flavor, and food coloring. Placebo capsules will contain lactose powder.
Overall Study STARTED	70	70
Overall Study COMPLETED	68	70
Overall Study NOT COMPLETED	2	0

Withdrawal data not reported

Antibiotics Versus Placebo in the Treatment of Abscesses in the Emergency Department

Baseline characteristics by cohort
Measure	Trimethoprim-sulfamethaxazole n=70 Participants Incision and drainage of the abscess and treatment with oral TMP-SMX (100 patients) Trimethoprim-sulfamethoxazole: 10mg/kg/day (based on trimethoprim component), divided twice daily for ten days (maximum dose: 160mg (TMP component) per dose)	Sugar Pill n=70 Participants Incision and drainage of the abscess and treatment with oral placebo (100 patients) Sugar pill: 10mg/kg/day divided twice daily for ten days. Placebo liquid will contain simple syrup, lactose powder, grape flavor, and food coloring. Placebo capsules will contain lactose powder.	Total n=140 Participants Total of all reporting groups
Age, Categorical <=18 years	70 Participants n=93 Participants	70 Participants n=4 Participants	140 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Female	38 Participants n=93 Participants	40 Participants n=4 Participants	78 Participants n=27 Participants
Sex: Female, Male Male	32 Participants n=93 Participants	30 Participants n=4 Participants	62 Participants n=27 Participants
Region of Enrollment United States	70 participants n=93 Participants	70 participants n=4 Participants	140 participants n=27 Participants

Timeframe: two years

Outcome measures
Measure	Trimethoprim-sulfamethaxazole n=70 Participants Incision and drainage of the abscess and treatment with oral TMP-SMX (100 patients) Trimethoprim-sulfamethoxazole: 10mg/kg/day (based on trimethoprim component), divided twice daily for ten days (maximum dose: 160mg (TMP component) per dose)	Sugar Pill n=70 Participants Incision and drainage of the abscess and treatment with oral placebo (100 patients) Sugar pill: 10mg/kg/day divided twice daily for ten days. Placebo liquid will contain simple syrup, lactose powder, grape flavor, and food coloring. Placebo capsules will contain lactose powder.
Health Outcomes After Use With Trimethoprim-sulfamethaxazole	0 Percentage of outcomes assessed	0 Percentage of outcomes assessed

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Children's Mercy Hospital

Phone: 8162343430