Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Adjunctive Clindamycin for Cellulitis: C4C Trial. (C4C)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01876628
Recruitment Status : Unknown
Verified November 2015 by University Hospitals Bristol NHS Foundation Trust.
Recruitment status was:  Active, not recruiting
First Posted : June 12, 2013
Last Update Posted : January 8, 2016
Sponsor:
Collaborators:
University of Bristol
Public Health England
Information provided by (Responsible Party):
University Hospitals Bristol NHS Foundation Trust

Tracking Information
First Submitted Date  ICMJE June 10, 2013
First Posted Date  ICMJE June 12, 2013
Last Update Posted Date January 8, 2016
Study Start Date  ICMJE October 2013
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 1, 2014)
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
Original Primary Outcome Measures  ICMJE
 (submitted: June 11, 2013)
Improvement based on a composite of systemic and local features [ Time Frame: Day 5 ]
Temperature less than 37.5 degrees centigrade, and a reduction in limb swelling
Change History Complete list of historical versions of study NCT01876628 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2013)
  • Decrease in pain [ Time Frame: Day 10 ]
    Assessed using a visual analogue score
  • 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.
  • Physiological recovery [ Time Frame: Day 10 ]
    Resolution of systemic features, composite inflammatory markers and recovery of renal function.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adjunctive Clindamycin for Cellulitis: C4C Trial.
Official Title  ICMJE A Double Blind Randomised Control Trial to Measure the Effect of the Addition of Clindamycin to Flucloxacillin for the Treatment of Limb Cellulitis
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cellulitis
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Placebo Comparator: Flucloxacillin and placebo
    Intravenous or oral Flucloxacillin with an oral placebo
    Intervention: Drug: Flucloxacillin and placebo
  • Active Comparator: Flucloxacillin and Clindamycin
    Intravenous or oral Flucloxacillin with oral Clindamycin
    Intervention: Drug: Flucloxacillin and Clindamycin
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 11, 2013)
450
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2016
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01876628
Other Study ID Numbers  ICMJE C4C-4078
2013-001218-14 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospitals Bristol NHS Foundation Trust
Study Sponsor  ICMJE University Hospitals Bristol NHS Foundation Trust
Collaborators  ICMJE
  • University of Bristol
  • Public Health England
Investigators  ICMJE Not Provided
PRS Account University Hospitals Bristol NHS Foundation Trust
Verification Date November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP