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Penicillin to prevent recurrent leg cellulitis

Thomas, KS; Crook, AM; Nunn, AJ; Foster, KA; Mason, JM; Chalmers, JR; Ibrahim , SN; Brindle, RJ; English, J; Merekith, SK; Reynolds, NJ; de Berker, MD; Mortimer, PS; Williams, HC

Authors

KS Thomas

AM Crook

AJ Nunn

KA Foster

JM Mason

JR Chalmers

SN Ibrahim

RJ Brindle

J English

SK Merekith

NJ Reynolds

MD de Berker

PS Mortimer

HC Williams



Abstract

Background: Cellulitis of the leg is a common bacterial infection of the skin and underlying tissue. We compared prophylactic low-dose penicillin with placebo for the prevention of recurrent cellulitis. Methods: We conducted a double-blind, randomized, controlled trial involving patients with two or more episodes of cellulitis of the leg who were recruited in 28 hospitals in the United Kingdom and Ireland. Randomization was performed according to a computer-generated code, and study medications (penicillin [250 mg twice a day] or placebo for 12 months) were dispensed by a central pharmacy. The primary outcome was the time to a first recurrence. Participants were followed for up to 3 years. Because the risk of recurrence was not constant over the 3-year period, the primary hypothesis was tested during prophylaxis only. Results: A total of 274 patients were recruited. Baseline characteristics were similar in the two groups. The median time to a first recurrence of cellulitis was 626 days in the penicillin group and 532 days in the placebo group. During the prophylaxis phase, 30 of 136 participants in the penicillin group (22%) had a recurrence, as compared with 51 of 138 participants in the placebo group (37%) (hazard ratio, 0.55; 95% confidence interval [CI], 0.35 to 0.86; P=0.01), yielding a number needed to treat to prevent one recurrent cellulitis episode of 5 (95% CI, 4 to 9). During the no-intervention follow-up period, there was no difference between groups in the rate of a first recurrence (27% in both groups). Overall, participants in the penicillin group had fewer repeat episodes than those in the placebo group (119 vs. 164, P=0.02 for trend). There was no significant between-group difference in the number of participants with adverse events (37 in the penicillin group and 48 in the placebo group, P=0.50). Conclusions: In patients with recurrent cellulitis of the leg, penicillin was effective in preventing subsequent attacks during prophylaxis, but the protective effect diminished progressively once drug therapy was stopped.

Citation

Thomas, K., Crook, A., Nunn, A., Foster, K., Mason, J., Chalmers, J., …Williams, H. (2013). Penicillin to prevent recurrent leg cellulitis. New England Journal of Medicine, 368(18), 1695-1703. https://doi.org/10.1056/nejmoa1206300

Journal Article Type Article
Publication Date May 1, 2013
Deposit Date May 9, 2013
Journal New England Journal of Medicine
Print ISSN 0028-4793
Electronic ISSN 1533-4406
Publisher Massachusetts Medical Society
Peer Reviewed Peer Reviewed
Volume 368
Issue 18
Pages 1695-1703
DOI https://doi.org/10.1056/nejmoa1206300