A Phase 4 interventional study of Flucloxacillin and Clindamycin in Cellulitis, sponsored by University Hospitals Bristol and Weston NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-17.
Sponsored by University Hospitals Bristol and Weston NHS Foundation Trust · Phase 4, Interventional, and Treatment
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.
Criteria to be used to assess tissue damage and clinical response:
160 studies on the registry are indexed under Cellulitis; 14 are open to participants now.
This study's enrollment of 410 is above the median of 157 across 124 interventional studies indexed under Cellulitis.
Browse Cellulitis studies →University Hospitals Bristol and Weston NHS Foundation Trust is the lead sponsor of 24 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Intravenous or oral Flucloxacillin with a Placebo oral capsule
Drug: Flucloxacillin · Drug: Placebo oral capsule
Intravenous or oral Flucloxacillin with Clindamycin oral capsule
Drug: Flucloxacillin · Drug: Clindamycin
Intravenous or oral Flucloxacillin. Minimum dose 500mg four times each day. Target duration 5 days less pre-recruitment beta-lactam duration.
Also known as: Floxapen, Fluclomix, Ladropen
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.
Also known as: Dalacin C, Daclin, Cleocin
Placebo is externally identical to the over-encapsulated clindamycin and is taken four times each day for 2 days
Improvement based on a composite of systemic and local features
Temperature less than 37.5 degrees centigrade, reduction in limb swelling and reduction in skin temperature
Time frame: Day 5
Decrease in pain
Assessed using a visual analogue score
Time frame: Day 10
Quality of life
Assessment based on a questionnaire plus return to work or normal activities and absence of increased side-effects.
Time frame: Day 30
Physiological recovery
Resolution of systemic features, composite inflammatory markers and recovery of renal function.
Time frame: Day 10
Plan to share: Yes
The record gives a start of Oct 2013, a primary completion of Dec 2015 and a completion of Mar 2016. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Clindamycin
University Hospitals Bristol and Weston NHS Foundation Trust