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:
- 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
Sponsor: University Hospitals Bristol NHS Foundation Trust
Current Primary Outcome: Improvement based on a composite of systemic and local features [ Time Frame: Day 5 ]
Original Primary Outcome: Improvement based on a composite of systemic and local features [ Time Frame: Day 5 ]
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