Adjunctive Clindamycin for Cellulitis: C4C Trial.

Study Overview
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Brief Summary
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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
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Criteria to be used to assess tissue damage and clinical response: Fever, tachycardia, neutrophil count, urea and other laboratory parameters at five and ten days post first dose of clindamycin Limb swelling (by the measurement of limb circumference), skin surface temperature and tissue damage (by the proportion of the limb affected) Document the duration between initial systemic features and the development of local signs Examine the effect of the duration between systemic and local features and first dose of flucloxacillin on the subsequent duration and severity of cellulitis 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 Identify and quantify possible side effects of clindamycin

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

Conditions
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Cellulitis

Intervention / Treatment
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* Drug: Flucloxacillin
* Drug: Clindamycin
* Drug: Placebo oral capsule


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Flucloxacillin and Placebo oral capsule<br>Intravenous or oral Flucloxacillin with a Placebo oral capsule | Drug: Flucloxacillin<br>* Intravenous or oral Flucloxacillin. Minimum dose 500mg four times each day. Target duration 5 days less pre-recruitment beta-lactam duration.<br>* Other names: Ladropen;Drug: Placebo oral capsule<br>* Placebo is externally identical to the over-encapsulated clindamycin and is taken four times each day for 2 days<br>|
| Active Comparator: Flucloxacillin and Clindamycin<br>Intravenous or oral Flucloxacillin with Clindamycin oral capsule | Drug: Flucloxacillin<br>* Intravenous or oral Flucloxacillin. Minimum dose 500mg four times each day. Target duration 5 days less pre-recruitment beta-lactam duration.<br>* Other names: Ladropen;Drug: Clindamycin<br>* 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.<br>* Other names: Cleocin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Day 5 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clindamycin, Cellulitis, Flucloxacillin, Group A streptococcus, Staphylococcus aureus