E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10007882 |
E.1.2 | Term | Cellulitis |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | 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
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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.
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E.5.2.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of trial is the date of the last telephone follow up or home visit or, if the patient is still in hospital after one month of study entry, the last review of the last participant. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 1 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 1 |