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Adjunctive Clindamycin for Cellulitis: C4C Trial.

NCT01876628 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 410

Last updated 2022-08-17

No results posted yet for this study

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.

Conditions

  • Cellulitis

Interventions

DRUG

Flucloxacillin

Intravenous or oral Flucloxacillin. Minimum dose 500mg four times each day. Target duration 5 days less pre-recruitment beta-lactam duration.

DRUG

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.

DRUG

Placebo oral capsule

Placebo is externally identical to the over-encapsulated clindamycin and is taken four times each day for 2 days

Sponsors & Collaborators

  • University of Bristol

    collaborator OTHER

  • Public Health England

    collaborator OTHER_GOV

  • University Hospitals Bristol and Weston NHS Foundation Trust

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2015-12-31
Completion
2016-03-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01876628 on ClinicalTrials.gov