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