Cellulitis MedDRA version: 16.0 Level: PT Classification code 10007882 Term: Cellulitis System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Clindamycin
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Clindamycin
CAS Number: 18323-44-9
Other descriptive name: 7-chloro-7-deoxylincomycin
Concentration unit: mg milligram
Sponsors
University Hospitals Bristol NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 300 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 150
Exclusion criteria
Exclusion criteria: Patients with a confirmed history of penicillin, flucloxacillin or clindamycin allergy. Patients known to be colonised with MRSA or MRSA isolated from wound within the last year. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 1. Compare with placebo the effect of adjunctive clindamycin on the resolution of systemic features of sepsis (e.g. fever, tachycardia, neutrophil count and urea) at five and ten days post first dose of clindamycin 2. Evaluate clindamycin’s effect on limb swelling (by the measurement of limb circumference) and tissue damage (by the proportion of the limb affected) 3. Perform an economic evaluation to determine the cost-effectiveness of adjunctive clindamycin at 30 days. 4. Evaluate clindamycin’s effect on haematological parameters (e.g. white cell count, renal function and albumin) and how these relate to systemic and local features of cellulitis, to provide objective measures of severity 5. Document the duration between initial systemic features and the development of local signs (e.g.. swelling, pain, blistering and rash) 6. Examine the effect of the duration between systemic and local features and first dose of flucloxacillin on the subsequent duration and severity of celluliti;Primary end point(s): Primary outcome: Improvement at day 5 (range 4-6) based on a composite of systemic and local features: Temperature less than 37.5C, Reduction in limb swelling Reduction in local skin temperature ;Timepoint(s) of evaluation of this end point: Day 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Decrease in pain using a visual analogue score (VAS) at 30 days, Quality of life, measured by the Euroqol questionnaire at 30 days, that would allow to derive short-term Quality Adjusted Life Years Resolution of systemic features, resolution of composite inflammatory markers, Recovery of renal function, Return to work or normal activities, Absence of increased side-effects. ;Timepoint(s) of evaluation of this end point: VAS, Euroquol and return to normal activities at 30 days Systemic features, renal function and side effects at Day 5 and Day 10 | — |
Countries
United Kingdom
Outcome results
None listed