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Trial Outcomes & Findings for Management of Skin and Soft Tissue Abscesses in Pediatric Patients After Incision and Drainage (NCT NCT00691600)

NCT ID: NCT00691600

Last Updated: 2020-07-01

Results Overview

Outcomes will be measured by resolution of size, tenderness, and induration with erythema by parental report 7 - 10 days after initial visit to the Emergency Center

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

23 participants

Primary outcome timeframe

10 days

Results posted on

2020-07-01

Participant Flow

Participant milestones

Participant milestones
Measure
Antibiotic Arm
subjects with abscesses less than 5cm will be randomized to oral trimethoprim/sulfamethoxazole: 80 mg caps or 8 mg/ml suspension every 12 hours for 10 days
Placebo Arm
Patients with abscesses \< 5cm randomized to placebo tablets or suspension twice a day for 10 days
Overall Study
STARTED
12
11
Overall Study
COMPLETED
12
11
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Management of Skin and Soft Tissue Abscesses in Pediatric Patients After Incision and Drainage

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Oral Trimethoprim/Sulfamethoxazole
n=12 Participants
subjects with abscesses less than 5cm will be randomized to study medication, oral trimethoprim/sulfamethoxazole: 80 mg caps or 8 mg/ml suspension every 12 hours for 10 days
Placebo After Incision and Drainage
n=11 Participants
Patients with abscesses less than 5cm will be randomized to receive placebo. Placebo: Placebo capsules every 12 hours for 10 days
Total
n=23 Participants
Total of all reporting groups
Age, Categorical
<=18 years
12 Participants
n=5 Participants
11 Participants
n=7 Participants
23 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Sex: Female, Male
Female
5 Participants
n=5 Participants
5 Participants
n=7 Participants
10 Participants
n=5 Participants
Sex: Female, Male
Male
7 Participants
n=5 Participants
6 Participants
n=7 Participants
13 Participants
n=5 Participants
Region of Enrollment
United States
12 participants
n=5 Participants
11 participants
n=7 Participants
23 participants
n=5 Participants

PRIMARY outcome

Timeframe: 10 days

Population: Intention to treat

Outcomes will be measured by resolution of size, tenderness, and induration with erythema by parental report 7 - 10 days after initial visit to the Emergency Center

Outcome measures

Outcome measures
Measure
Antibiotic Arm
n=12 Participants
oral trimethoprim/sulfamethoxazole: 80 mg caps or 8 mg/ml suspension every 12 hours for 10 days
Placebo Arm
n=11 Participants
Receipt of placebo in either capsule or suspension formulation twice daily for 10 days
Number of Participants With Abscess Resolution
11 Participants
9 Participants

SECONDARY outcome

Timeframe: 10 days

Percentage of patients requiring admission to Texas Children's or another hospital within 10 days of incision and drainage

Outcome measures

Outcome measures
Measure
Antibiotic Arm
n=12 Participants
oral trimethoprim/sulfamethoxazole: 80 mg caps or 8 mg/ml suspension every 12 hours for 10 days
Placebo Arm
n=11 Participants
Receipt of placebo in either capsule or suspension formulation twice daily for 10 days
Number of Participants Requiring Admission for Failure of Abscess Resolution
0 Participants
0 Participants

SECONDARY outcome

Timeframe: 10 days

For the antibiotic arm, we determined if the child was prescribed a different antibiotic. For the placebo arm, we determined if the child received a prescription for an antibiotic at a subsequent visit (e.g., in the emergency department, by their pediatrician, etc) within 10 days of incision and drainage

Outcome measures

Outcome measures
Measure
Antibiotic Arm
n=12 Participants
oral trimethoprim/sulfamethoxazole: 80 mg caps or 8 mg/ml suspension every 12 hours for 10 days
Placebo Arm
n=11 Participants
Receipt of placebo in either capsule or suspension formulation twice daily for 10 days
Number of Participants Requiring New or Modified Antibiotics for Failure of Abscess to Resolve
1 Participants
2 Participants

Adverse Events

Antibiotic Arm

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Placebo Arm

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

Andrea T. Cruz, MD, MPH

Baylor College of Medicine

Phone: 832-824-5582

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place