Adjunctive Clindamycin for Cellulitis: C4C Trial.

University Hospitals Bristol and Weston NHS Foundation Trust410 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

410

Conditions

Cellulitis

Interventions

FlucloxacillinDRUG

Intravenous or oral Flucloxacillin. Minimum dose 500mg four times each day. Target duration 5 days less pre-recruitment beta-lactam duration.

ClindamycinDRUG

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.

Placebo oral capsuleDRUG

Placebo is externally identical to the over-encapsulated clindamycin and is taken four times each day for 2 days

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospitals Bristol NHS Foundation Trust

Bristol, United Kingdom

Outcomes

Primary Outcomes

Improvement based on a composite of systemic and local features

Temperature less than 37.5 degrees centigrade, reduction in limb swelling and reduction in skin temperature

Time frame: Day 5

Secondary Outcomes

Decrease in pain

Assessed using a visual analogue score

Time frame: Day 10

Quality of life

Assessment based on a questionnaire plus return to work or normal activities and absence of increased side-effects.

Time frame: Day 30

Physiological recovery

Resolution of systemic features, composite inflammatory markers and recovery of renal function.

Time frame: Day 10

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.