PATCH-I
Trial question
What is the role of low-dose penicillin in patients with recurrent cellulitis?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
60.0% female
40.0% male
N = 274
274 patients (165 female, 109 male).
Inclusion criteria: patients with ≥ 2 episodes of cellulitis of the leg.
Key exclusion criteria: use of antibiotics for the prevention of cellulitis in the preceding 6 months; allergy to penicillin; previous leg ulceration, surgery, or penetrating trauma; an age of < 16 years.
Interventions
N=136 penicillin (250 mg BID for 12 months).
N=138 placebo (matching placebo BID for 12 months).
Primary outcome
First cellulitis recurrence, during prophylaxis phase
22%
37%
37.0 %
27.8 %
18.5 %
9.3 %
0.0 %
Penicillin
Placebo
Significant
decrease ▼
NNT = 6
Significant decrease in first cellulitis recurrence, during the prophylaxis phase (22% vs. 37%; HR 0.55, 95% CI 0.35 to 0.86).
Secondary outcomes
No significant difference in first cellulitis recurrence, during the no-intervention follow-up period (27% vs. 27%; HR 1.08, 95% CI 0.61 to 1.93).
Safety outcomes
No significant differences in adverse events (37 vs. 48, p=0.50).
Conclusion
In patients with ≥ 2 episodes of cellulitis of the leg, penicillin was superior to placebo with respect to first cellulitis recurrence, during the prophylaxis phase.
Reference
Thomas KS, Crook AM, Nunn AJ et al. Penicillin to prevent recurrent leg cellulitis. N Engl J Med. 2013 May 2;368(18):1695-703.
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