Adjunctive Clindamycin for Cellulitis: Clinical Trial Comparing Flucloxacillin With or Without Clindamycin for the Treatment of Limb Cellulitis (C4C Trial).

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by University Hospitals Bristol NHS Trust
Sponsor:
Collaborators:
University of Bristol
Health Protection Agency, United Kingdom
Information provided by (Responsible Party):
University Hospitals Bristol NHS Trust
ClinicalTrials.gov Identifier:
NCT01876628
First received: June 10, 2013
Last updated: October 30, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Cellulitis
Drug: Flucloxacillin and Clindamycin
Drug: Flucloxacillin and placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University Hospitals Bristol NHS Trust:

Primary Outcome Measures:
  • Improvement based on a composite of systemic and local features [ Time Frame: Day 5 ] [ Designated as safety issue: No ]
    Temperature less than 37.5 degrees centigrade, and a reduction in limb swelling


Secondary Outcome Measures:
  • Decrease in pain [ Time Frame: Day 10 ] [ Designated as safety issue: No ]
    Assessed using a visual analogue score

  • Quality of life [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
    Assessment based on a questionnaire plus return to work or normal activities and absence of increased side-effects.

  • Physiological recovery [ Time Frame: Day 10 ] [ Designated as safety issue: No ]
    Resolution of systemic features, composite inflammatory markers and recovery of renal function.


Estimated Enrollment: 450
Study Start Date: October 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Flucloxacillin and placebo
Intravenous or oral Flucloxacillin with an oral placebo
Drug: Flucloxacillin and placebo
Placebo is externally identical to the over-encapsulated clindamycin and is taken four times each day for 2 days
Other Names:
  • Floxapen
  • Fluclomix
  • Ladropen
Active Comparator: Flucloxacillin and Clindamycin
Intravenous or oral Flucloxacillin with oral Clindamycin
Drug: Flucloxacillin and 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.
Other Names:
  • Floxapen
  • Fluclomix
  • Ladropen
  • Dalacin C
  • Lincocin
  • Daclin

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01876628

Contacts
Contact: Richard Brindle, DM +441173423365 richard.brindle@uhbristol.nhs.uk

Locations
United Kingdom
University Hospitals Bristol NHS Foundation Trust Recruiting
Bristol, United Kingdom, BS2 8HW
Contact: Richard Brindle, DM       bristol.cellulitis@uhbristol.nhs.uk   
Contact: Martin O Williams, PhD, MB BCh       bristol.cellulitis@uhbristol.nhs.uk   
Principal Investigator: Richard Brindle, DM         
Sponsors and Collaborators
University Hospitals Bristol NHS Trust
University of Bristol
Health Protection Agency, United Kingdom
  More Information

No publications provided

Responsible Party: University Hospitals Bristol NHS Trust
ClinicalTrials.gov Identifier: NCT01876628     History of Changes
Other Study ID Numbers: C4C-4078, 2013-001218-14
Study First Received: June 10, 2013
Last Updated: October 30, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: National Institute for Health Research
United Kingdom: National Health Service
United Kingdom: Department of Health
United Kingdom: Research Ethics Committee

Keywords provided by University Hospitals Bristol NHS Trust:
Clindamycin
Cellulitis
Flucloxacillin
Group A streptococcus
Staphylococcus aureus

Additional relevant MeSH terms:
Cellulitis
Skin Diseases, Infectious
Infection
Suppuration
Connective Tissue Diseases
Inflammation
Pathologic Processes
Floxacillin
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014