Clinical trial NCT01876628: Adjunctive Clindamycin for Cellulitis: C4C Trial.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cellulitis
Keywords: Clindamycin
Cellulitis
Flucloxacillin
Group A streptococcus
Staphylococcus aureus
Lead sponsor: University Hospitals Bristol and Weston NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Bristol
name: Public Health England
First posted: 2013-06-12
Enrollment: 410
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: Improvement based on a composite of systemic and local features
timeFrame: Day 5
Secondary outcomes:
measure: Decrease in pain
timeFrame: Day 10
measure: Quality of life
timeFrame: Day 30
measure: Physiological recovery
timeFrame: Day 10
Other outcomes:
Locations:
city: Bristol
country: United Kingdom
facility: University Hospitals Bristol NHS Foundation Trust
Study officials:
References:
citation: Brindle R, Williams OM, Davies P, Harris T, Jarman H, Hay AD, Featherstone P. Adjunctive clindamycin for cellulitis: a clinical trial comparing flucloxacillin with or without clindamycin for the treatment of limb cellulitis. BMJ Open. 2017 Mar 17;7(3):e013260. doi: 10.1136/bmjopen-2016-013260.