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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-001218-14 | EudraCT Number |
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| Name | Class |
|---|---|
| University of Bristol | OTHER |
| Public Health England | OTHER_GOV |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flucloxacillin and Placebo oral capsule | Placebo Comparator | Intravenous or oral Flucloxacillin with a Placebo oral capsule |
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| Flucloxacillin and Clindamycin | Active Comparator | Intravenous or oral Flucloxacillin with Clindamycin oral capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flucloxacillin | Drug | Intravenous or oral Flucloxacillin. Minimum dose 500mg four times each day. Target duration 5 days less pre-recruitment beta-lactam duration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Decrease in pain | Assessed using a visual analogue score | Day 10 |
| Quality of life | Assessment based on a questionnaire plus return to work or normal activities and absence of increased side-effects. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Bristol NHS Foundation Trust | Bristol | BS2 8HW | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28314743 | Derived | Brindle R, Williams OM, Davies P, Harris T, Jarman H, Hay AD, Featherstone P. Adjunctive clindamycin for cellulitis: a clinical trial comparing flucloxacillin with or without clindamycin for the treatment of limb cellulitis. BMJ Open. 2017 Mar 17;7(3):e013260. doi: 10.1136/bmjopen-2016-013260. |
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| ID | Term |
|---|---|
| D002481 | Cellulitis |
| D013203 | Staphylococcal Infections |
| ID | Term |
|---|---|
| D012874 | Skin Diseases, Infectious |
| D007239 | Infections |
| D013492 | Suppuration |
| D003240 | Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D005436 | Floxacillin |
| D002981 | Clindamycin |
| ID | Term |
|---|---|
| D003023 | Cloxacillin |
| D010068 | Oxacillin |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 |
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|
| Clindamycin | Drug | 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. |
|
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| Placebo oral capsule | Drug | Placebo is externally identical to the over-encapsulated clindamycin and is taken four times each day for 2 days |
|
| Day 30 |
| Physiological recovery | Resolution of systemic features, composite inflammatory markers and recovery of renal function. | Day 10 |
| D017437 |
| Skin and Connective Tissue Diseases |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D008034 | Lincomycin |
| D055231 | Lincosamides |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006027 | Glycosides |
| D002241 | Carbohydrates |