Adjunctive Clindamycin For Cellulitis clinical trial (C4C)

Phase 4

Completed

• Conditions: Topic: Injuries and Emergencies, Skin; Subtopic: Injuries and Emergencies (all Subtopics), Skin (all Subtopics); Disease: Injuries and Emergencies, Dermatology; Skin and Connective Tissue Diseases; Cellulitis, unspecified

• Registration Number: ISRCTN86329346
• Lead Sponsor: niversity Hospitals Bristol NHS Foundation Trust (UK)

Brief Summary

2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28314743

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-10-25
• Study Completion: 2016-03-31
• Last Update Posted: 11 June 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

1. Male or female subjects aged 18 or over who have a diagnosis of cellulitis of a single, upper or lower, limb
2. Who are able to understand the study and give consent
3. Who are able to take oral medication

Exclusion Criteria

1. Patients with a confirmed history of penicillin, flucloxacillin or clindamycin allergy
2. Patients known to be colonised with MRSA or MRSA isolated from wound within the last year
3. Unable to take oral medication
4. Previous history of Clostridium difficile colitis
5. Clindamycin taken within the last 30 days
6. Clinically unstable
7. Unable to understand the study or give consent
8. Any doubt over the certainty of the diagnosis of cellulitis
9. Patients taking any drug that is incompatible with either flucloxacillin or clindamycin

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement of systemic and local features; Timepoint(s): Day 1 and Day 5

Secondary Outcome Measures

Name	Time	Method
1. Decrease in pain using a visual analogue score (VAS); Timepoint(s): Day 1, Day 5 and Day 10<br>2. Quality adjusted life years (QALYs) based on the EQ-5D-5L; Timepoint(s): Day 1 and Day 30<br>3. Recovery of renal function; Timepoint(s): Day 1, Day 5 and Day 10<br>4. Resolution of composite inflammatory markers; Timepoint(s): Day 1, Day 5 and Day 10<br>5. Resolution of systemic features; Timepoint(s): Day 1, Day 5 and Day 10<br>6. Return to work or normal activities; Timepoint(s): Day 1 and Day 30