Abstract
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.
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.
| Original language | English |
|---|---|
| Article number | e013260 |
| Number of pages | 10 |
| Journal | BMJ Open |
| Volume | 7 |
| Issue number | 3 |
| Early online date | 17 Mar 2017 |
| DOIs | |
| Publication status | Published - Mar 2017 |
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This is the final published version of the article (version of record). It first appeared online via BMJ at DOI:10.1136/bmjopen-2016-013260. Please refer to any applicable terms of use of the publisher.
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Data from: Adjunctive clindamycin for cellulitis: clinical trial comparing flucloxacillin with or without clindamycin for the treatment of limb cellulitis
Brindle, R. (Contributor), Williams, O. M. (Contributor), Davies, P. (Contributor), Harris, T. (Contributor), Jarman, H. (Contributor), Hay, A. D. (Contributor) & Featherstone, P. (Contributor), Dryad, 10 Mar 2017
DOI: 10.5061/dryad.5q1j0, http://datadryad.org/stash/dataset/doi:10.5061/dryad.5q1j0
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