Skip to main content
OpenTrials
Completed

NCT Number: NCT01876628

Adjunctive Clindamycin for Cellulitis: C4C Trial.

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cellulitis Bacterial Infections Bacterial Infections and Mycoses Connective Tissue Diseases Gram-Positive Bacterial Infections Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases, Infectious Skin and Connective Tissue Diseases Staphylococcal Infections Suppuration

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospitals Bristol NHS Foundation Trust

Bristol, BS2 8HW, United Kingdom

About this study

Criteria to be used to assess tissue damage and clinical response:

  • Fever, tachycardia, neutrophil count, urea and other laboratory parameters at five and ten days post first dose of clindamycin
  • Limb swelling (by the measurement of limb circumference), skin surface temperature and tissue damage (by the proportion of the limb affected)
  • Document the duration between initial systemic features and the development of local signs
  • Examine the effect of the duration between systemic and local features and first dose of flucloxacillin on the subsequent duration and severity of cellulitis
  • 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
  • Identify and quantify possible side effects of clindamycin

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Flucloxacillin

Drug

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

Other names: Floxapen, Fluclomix, Ladropen

Clindamycin

Drug

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.

Other names: Dalacin C, Daclin, Cleocin

Placebo oral capsule

Drug

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

Primary outcomes

  1. Improvement based on a composite of systemic and local features

    Time frame: Day 5

    Temperature less than 37.5 degrees centigrade, reduction in limb swelling and reduction in skin temperature

Secondary outcomes

  1. Decrease in pain

    Time frame: Day 10

    Assessed using a visual analogue score

  2. Quality of life

    Time frame: Day 30

    Assessment based on a questionnaire plus return to work or normal activities and absence of increased side-effects.

  3. Physiological recovery

    Time frame: Day 10

    Resolution of systemic features, composite inflammatory markers and recovery of renal function.

Sponsors and collaborators

Lead sponsor

University Hospitals Bristol and Weston NHS Foundation Trust

Other

Collaborators

  • Public Health England
  • University of Bristol

Registry information

Official study title

A Double Blind Randomised Control Trial to Measure the Effect of the Addition of Clindamycin to Flucloxacillin for the Treatment of Limb Cellulitis

Acronym: C4C

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Jun 12, 2013
Registry last updated
Aug 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.