Clinical Trial: Adjunctive Clindamycin for Cellulitis: C4C Trial.

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

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 Summary:

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

Sponsor: University Hospitals Bristol NHS Foundation Trust

Current Primary Outcome: 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: 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


Current Secondary Outcome:

  • 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: Same as current

Information By: University Hospitals Bristol NHS Foundation Trust

Dates:
Date Received: June 10, 2013
Date Started: October 2013
Date Completion: January 2016
Last Updated: January 7, 2016
Last Verified: November 2015