Methods |
A randomised controlled trial |
Participants |
Inclusion criteria:
Patients aged 6 months to 18 years (inclusive) who presented to a paediatric outpatient centre at Johns Hopkins (paediatric emergency department or paediatric outpatient department)
With an uncomplicated, purulent skin and soft tissue infections (SSTI), defined as an abscess (with or without surrounding cellulitis), furuncle, or carbuncle for which outpatient management was anticipated
Exclusion criteria:
Hospitalisation on initial visit or previous 14 days
Hypersensitivity to cephalosporin antibiotics or clindamycin
Inherited or acquired altered immunity (such as HIV infection, uncontrolled diabetes mellitus, congenital immunodeficiency)
Skin infections related to surgical wounds or hardware
Current use of antibiotic therapy
Of 220 patients screened, 200 were enrolled in the study. 100 participants were randomly assigned to receive cefalexin and 100 to receive clindamycin. |
Interventions |
Intervention 1 (cefalexin group): participants took cefalexin 40 mg/kg per day in divided doses administered 3 times per day. Intervention 2 (clindamycin group): participants took clindamycin 20 or 40 mg/kg per day in divided doses administered 3 times per day. |
Outcomes |
Primary outcome:
Clinical improvement at 48 to 72 hours from the initiation of treatment, defined as improvement in at least 1 of the measured parameters (overall improvement according to participant or parent/guardian, fever, erythema, pain/tenderness, and drainage) without worsening in any of those parameters
Secondary outcome:
Resolution of disease at 7 days, defined as overall improvement according to the participant or parent/guardian in addition to resolution of all variables (fever, erythema, pain/tenderness, and drainage)
|
Notes |
Location: Johns Hopkins in the United States Sponsor: National Institutes of Health (NIH) |