Adjunctive Clindamycin for Cellulitis: C4C Trial.

• Status: Unknown status
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospitals Bristol and Weston NHS Foundation Trust; University Hospitals Bristol NHS Foundation Trust
• Collaborators: Public Health England; University of Bristol
• Treatments: Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Floxacillin

Criteria

Inclusion Criteria:

• Male or female subjects aged 18 or over who have a diagnosis of cellulitis of a single, upper or lower, limb

• Who are able to understand the study and give consent

• Who are able to take oral medication

Exclusion Criteria:

• Patients with a confirmed history of penicillin, flucloxacillin or clindamycin allergy

• Patients known to be colonised with Methicillin-resistant Staphylococcus aureus or Methicillin-resistant Staphylococcus aureus isolated from wound within the last year

• Patients unable to take oral medication

• Previous history of Clostridium difficile colitis

• Clindamycin taken within the last 30 days

• Clinically unstable

• Unable to understand the study or give consent

• Any doubt over the certainty of the diagnosis of cellulitis

• Patients taking any drug that is incompatible with either flucloxacillin or clindamycin

• Pre-existing diarrhoea