NCT01876628

Adjunctive Clindamycin for Cellulitis: C4C Trial.

A Double Blind Randomised Control Trial to Measure the Effect of the Addition of Clindamycin to Flucloxacillin for the Treatment of Limb Cellulitis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 410 (actual)
• Sponsor: University Hospitals Bristol and Weston NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to see whether the addition of Clindamycin, a protein inhibiting antibiotic, to the standard antibiotic treatment of limb cellulitis, with Flucloxacillin, results in less tissue damage and a more rapid resolution of both systemic and local features, in a cost-effective manner. This study is a randomised controlled trial comparing Clindamycin with placebo.

Detailed description

Criteria to be used to assess tissue damage and clinical response: 1. Fever, tachycardia, neutrophil count, urea and other laboratory parameters at five and ten days post first dose of clindamycin 2. Limb swelling (by the measurement of limb circumference), skin surface temperature and tissue damage (by the proportion of the limb affected) 3. Document the duration between initial systemic features and the development of local signs 4. Examine the effect of the duration between systemic and local features and first dose of flucloxacillin on the subsequent duration and severity of cellulitis 5. Examine the effect of duration between the first dose of flucloxacillin and the first dose of clindamycin on the subsequent duration and severity of cellulitis 6. Identify and quantify possible side effects of clindamycin

Conditions

• Cellulitis

Interventions

Type	Name	Description
DRUG	Flucloxacillin	Intravenous or oral Flucloxacillin. Minimum dose 500mg four times each day. Target duration 5 days less pre-recruitment beta-lactam duration.
DRUG	Clindamycin	Clindamycin dose 300mg four times each day for 2 days, within 48 hours of commencing flucloxacillin. Clindamycin is over-encapsulated and externally identical to placebo.
DRUG	Placebo oral capsule	Placebo is externally identical to the over-encapsulated clindamycin and is taken four times each day for 2 days

Timeline

• Start date: 2013-10-01
• Primary completion: 2015-12-01
• Completion: 2016-03-01
• First posted: 2013-06-12
• Last updated: 2022-08-17

Locations

1 site across 1 country: United Kingdom