Adjunctive Clindamycin for Cellulitis: C4C Trial.

Phase 4

Completed

• Conditions: Cellulitis
• Interventions: Drug: Flucloxacillin; Drug: Placebo oral capsule; Drug: Clindamycin

• Registration Number: NCT01876628
• Lead Sponsor: University Hospitals Bristol and Weston NHS Foundation Trust

Brief 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

Study Timeline

• Study First Submitted: 2013-06-10
• Study First Submitted QC: 2013-06-11
• Study First Posted: 2013-06-12
• Study Start: 2013-10
• Primary Completion: 2015-12
• Study Completion: 2016-03
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-16
• Last Update Posted: 2022-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 410

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Flucloxacillin and Placebo oral capsule	Placebo oral capsule	Intravenous or oral Flucloxacillin with a Placebo oral capsule
Flucloxacillin and Placebo oral capsule	Flucloxacillin	Intravenous or oral Flucloxacillin with a Placebo oral capsule
Flucloxacillin and Clindamycin	Flucloxacillin	Intravenous or oral Flucloxacillin with Clindamycin oral capsule
Flucloxacillin and Clindamycin	Clindamycin	Intravenous or oral Flucloxacillin with Clindamycin oral capsule

Primary Outcome Measures

Name	Time	Method
Improvement based on a composite of systemic and local features	Day 5	Temperature less than 37.5 degrees centigrade, reduction in limb swelling and reduction in skin temperature

Secondary Outcome Measures

Name	Time	Method
Decrease in pain	Day 10	Assessed using a visual analogue score
Quality of life	Day 30	Assessment based on a questionnaire plus return to work or normal activities and absence of increased side-effects.
Physiological recovery	Day 10	Resolution of systemic features, composite inflammatory markers and recovery of renal function.

Trial Locations

Locations (1)

University Hospitals Bristol NHS Foundation Trust; 🇬🇧 Bristol, United Kingdom