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Adjunctive Clindamycin for Cellulitis: Clinical Trial Comparing Flucloxacillin With or Without Clindamycin for the Treatment of Limb Cellulitis (C4C Trial).

Information source: University Hospitals Bristol NHS Foundation Trust
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cellulitis

Intervention: Flucloxacillin and Clindamycin (Drug); Flucloxacillin and placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University Hospitals Bristol NHS Foundation Trust

Overall contact:
Richard Brindle, DM, Phone: +441173423365, Email: richard.brindle@uhbristol.nhs.uk


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Improvement based on a composite of systemic and local features

Secondary outcome:

Decrease in pain

Quality of life

Physiological recovery

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


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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


- 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


- Pre-existing diarrhoea

Locations and Contacts

Richard Brindle, DM, Phone: +441173423365, Email: richard.brindle@uhbristol.nhs.uk

University Hospitals Bristol NHS Foundation Trust, Bristol BS2 8HW, United Kingdom; Recruiting
Richard Brindle, DM, Email: bristol.cellulitis@uhbristol.nhs.uk
Martin O Williams, PhD, MB BCh, Email: bristol.cellulitis@uhbristol.nhs.uk
Richard Brindle, DM, Principal Investigator
Additional Information

Starting date: October 2013
Last updated: December 1, 2014

Page last updated: August 23, 2015

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