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 and Weston NHS Foundation Trust.
Recruitment status was: Active, not recruiting
First Posted : June 12, 2013
Last Update Posted : January 8, 2016
|Condition or disease||Intervention/treatment||Phase|
|Cellulitis||Drug: Flucloxacillin and Clindamycin Drug: Flucloxacillin and placebo||Phase 4|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||450 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||January 2016|
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
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.
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01876628
|University Hospitals Bristol NHS Foundation Trust|
|Bristol, United Kingdom, BS2 8HW|