Data from: Adjunctive clindamycin for cellulitis: clinical trial comparing flucloxacillin with or without clindamycin for the treatment of limb cellulitis

Objective: To compare flucloxacillin with clindamycin to flucloxacillin
alone for the treatment of limb cellulitis. Design: Parallel,
double-blinded, randomised controlled trial. Setting: Emergency department
attendances and general practice referrals within 20 hospitals in England.
Interventions: Flucloxacillin, at a minimum of 500 mg 4 times per day for
5 days, with clindamycin 300 mg 4 times per day for 2 days given orally
versus flucloxacillin given alone. Main outcome measures: The primary
outcome was improvement at day 5. This was defined as being afebrile with
either a reduction in affected skin surface temperature or a reduction in
the circumference of the affected area. Secondary outcomes included
resolution of systemic features, resolution of inflammatory markers,
recovery of renal function, reduction in the affected area, decrease in
pain, return to work or normal activities and the absence of increased
side effects. Results: 410 patients were included in the trial. No
significant difference was seen in improvement at day 5 for flucloxacillin
with clindamycin (136/156, 87%) versus flucloxacillin alone (140/172,
81%)—OR 1.55 (95% CI 0.81 to 3.01), p=0.174. There was a significant
difference in the number of patients with diarrhoea at day 5 in the
flucloxacillin with clindamycin allocation (34/160, 22%) versus
flucloxacillin alone (16/176, 9%)—OR 2.7 (95% CI 1.41 to 5.07), p=0.002.
There was no clinically significant difference in any secondary outcome
measures. There was no significant difference in the number of patients
stating that they had returned to normal activities at the day 30
interview in the flucloxacillin with clindamycin allocation (99/121, 82%)
versus flucloxacillin alone (104/129, 81%)—adjusted OR 0.90 (95% CI 0.44
to 1.84). Conclusions: The addition of a short course of clindamycin to
flucloxacillin early on in limb cellulitis does not improve outcome. The
addition of clindamycin doubles the likelihood of diarrhoea within the
first few days.