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- Title
2015 - Clindamycin did not differ from trimethoprim-sulfamethoxazole for curing uncomplicated skin infections.
- Authors
Fekete, Thomas
- Abstract
Methods Design Randomized controlled trial. ClinicalTrials.gov NCT00730028. Allocation {Concealed}*.† Blinding Blinded† (patients, {clinicians, data collectors, outcome assessors, and safety committee}*). Follow-up period 40 days. Setting Urgent care clinics, emergency departments (EDs), and affiliated clinics at 4 sites in the USA. Patients 524 patients aged 6 months to 85 years (mean age 27 y, 30% children, 52% male) with uncomplicated skin infections (≥ 24 h with ≥ 2 of erythema, swelling or induration, local warmth, purulent drainage, and tenderness to pain or palpation), categorized as cellulitis (inflammation of the skin and associated structures without drainable fluid collection), abscess > 5.0 cm in diameter (drainable collection of pus, size proportionally smaller in children), or both. Exclusion criteria included superficial skin infections, human or animal bites, high fever, immunosuppressive medication use or immune-compromising conditions, surgical-site or prosthetic-device infection, or antibacterial treatment with antistaphylococcal activity. Intervention Clindamycin, 300 mg, 3 times/d (n = 264), or TMP-SMX, 160 mg of TMP and 800 mg of SMX, 2 times/d, plus placebo tablets at midday (n = 260), for 10 days. Pediatric doses were adjusted by body weight. All abscesses were incised and drained. Outcomes Primary outcome was clinical cure at 7 to 10 days after completion of treatment. Secondary outcomes included adverse events and clinical cure at 1 month overall and in subgroups (adults and children; cellulitis, abscess, and mixed cellulitis and abscess). 524 patients were required to detect a 10% between-group difference (85% vs. 95%) in cure rates, with a power of 80% (a = 0.05) and an assumed 20% attrition rate. Patient follow-up 89% were evaluated at 7 to 10 days. Main results 31% of patients had abscesses, 53% had cellulitis, and 16% had both. Clindamycin did not differ from TMP-SMX for cure of skin infection or adverse events at 7 to 10 days (Table) or at 1 month. Results did not vary by patient subgroups. Conclusion In patients with uncomplicated skin infections, clindamycin did not differ from trimethoprim-sulfamethoxazole for cure rates or adverse events.
- Subjects
UNITED States; ABSCESSES; OUTPATIENT medical care; CELLULITIS; CLINDAMYCIN; CLINICS; CO-trimoxazole; CONFIDENCE intervals; HOSPITAL emergency services; LONGITUDINAL method; MEDICAL cooperation; ORAL drug administration; RESEARCH; DECISION making in clinical medicine; STATISTICAL power analysis; RANDOMIZED controlled trials; RELATIVE medical risk; TREATMENT effectiveness; DESCRIPTIVE statistics
- Publication
ACP Journal Club, 2015, Vol 163, Issue 2, p8
- ISSN
1056-8751
- Publication type
Article