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Cellulitis | Adjunctive Clindamycin for Cellulitis: C4C Trial.

Cellulitis research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Cellulitis

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Flucloxacillin and ClindamycinClindamycin dose 300mg four times each day for 2 days, within 48 hours of commencing flucloxacillin. Clindamycin is over-encapsulated and externally identical to placebo.

Drug:Flucloxacillin and placeboPlacebo is externally identical to the over-encapsulated clindamycin and is taken four times each day for 2 days

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Flucloxacillin and placeboIntravenous or oral Flucloxacillin with an oral placebo

Flucloxacillin and ClindamycinIntravenous or oral Flucloxacillin with oral Clindamycin

Study Status

Unknown status

Start Date: October 2013

Completed Date: January 2016

Phase: Phase 4

Type: Interventional

Design:

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

Secondary Outcome: Decrease in pain

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: University Hospitals Bristol NHS Foundation Trust

Collaborator: University of Bristol

More information:https://clinicaltrials.gov/show/NCT01876628

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