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?
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
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
Start Date: October 2013
Completed Date: January 2016
Phase: Phase 4
Primary Outcome: Improvement based on a composite of systemic and local features
Secondary Outcome: Decrease in pain
Study sponsors, principal investigator, and references
Lead Sponsor: University Hospitals Bristol NHS Foundation Trust
Collaborator: University of Bristol