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Evaluation of 3 Versus 10 Days of Antibiotics in Skin Abscesses After Surgical Drainage

L

Lucy Holmes, MD

Status

Completed

Conditions

Skin Disease, Bacterial
Abscess

Treatments

Drug: Trimethoprim-Sulfamethoxazole

Study type

Interventional

Funder types

Other

Identifiers

NCT02024867
DB 2456

Details and patient eligibility

About

The objective of this study is to determine if there is a difference in treatment failures and recurrent skin infections when patients are given 3 or 10 days of antibiotics for uncomplicated skin abscesses after they have been surgically drained.

Full description

Patients age 3 months to 17 years presenting to a pediatric Emergency Department (ED) with an uncomplicated skin abscess that required surgical drainage were randomized to receive 3 or 10 days of oral trimethoprim-sulfamethoxazole. Patients were evaluated 10 to 14 days later to assess for cure. Patients were contacted 1 month later to determine if they had developed another skin infection. Outcomes were also stratified by methicillin-resistent staphylococcus aureus (MRSA) and methicillin-sensitive staphylococcus aureus (MSSA).

Enrollment

249 patients

Sex

All

Ages

3 months to 17 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • patients presenting with a skin abscess that requires surgical drainage (induration ≥ 1 cm in diameter)
  • minimally invasive surgical technique with the insertion of a subcutaneous drain can be utilized on the patient

Exclusion criteria

  • patients requiring immediate hospitalization
  • patients who have received 2 or more doses of antibiotics in the previous 36 hours
  • patients with diabetes, sickle-cell disease, an immuno-compromising disease, an underlying medical condition predisposing the patient to frequent hospitalizations or medical visits, or indwelling catheters or percutaneous medical devices
  • patients with a concurrent, non-abscess infection
  • patients with an allergy to Trimethoprim-sulfamethoxazole

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

249 participants in 2 patient groups

10 days of Trimethoprim-Sulfamethoxazole
Active Comparator group
Description:
Oral Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
Treatment:
Drug: Trimethoprim-Sulfamethoxazole
3 days of Trimethoprim-Sulfamethoxazole
Experimental group
Description:
Oral Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
Treatment:
Drug: Trimethoprim-Sulfamethoxazole

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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