Adjunctive Clindamycin for Cellulitis: C4C Trial.

Cellulitis Clinical Trial

— C4C  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01876628
• Other study ID #: C4C-4078
• Secondary ID: 2013-001218-14
• Status: Completed
• Phase: Phase 4
• Start date: October 2013
• Est. completion date: March 2016

Study information

• Verified date: August 2022
• Source: University Hospitals Bristol and Weston NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 410
• Est. completion date: March 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cellulitis

Intervention

Drug:
• Flucloxacillin
Intravenous or oral Flucloxacillin. Minimum dose 500mg four times each day. Target duration 5 days less pre-recruitment beta-lactam duration.
• Clindamycin
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.
• Placebo oral capsule
Placebo is externally identical to the over-encapsulated clindamycin and is taken four times each day for 2 days

Locations

Country	Name	City	State
United Kingdom	University Hospitals Bristol NHS Foundation Trust	Bristol

Sponsors (3)

Lead Sponsor	Collaborator
University Hospitals Bristol and Weston NHS Foundation Trust	Public Health England, University of Bristol

Country where clinical trial is conducted

United Kingdom, 

Outcome

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