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Adjunctive Clindamycin for Cellulitis: C4C Trial. (C4C)

Primary Purpose

Cellulitis

Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Flucloxacillin
Clindamycin
Placebo oral capsule
Sponsored by
University Hospitals Bristol and Weston NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cellulitis focused on measuring Clindamycin, Cellulitis, Flucloxacillin, Group A streptococcus, Staphylococcus aureus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Exclusion Criteria:

  • Patients with a confirmed history of penicillin, flucloxacillin or clindamycin allergy
  • Patients known to be colonised with Methicillin-resistant Staphylococcus aureus or Methicillin-resistant Staphylococcus aureus isolated from wound within the last year
  • Patients 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
  • Pre-existing diarrhoea

Sites / Locations

  • University Hospitals Bristol NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Flucloxacillin and Placebo oral capsule

Flucloxacillin and Clindamycin

Arm Description

Intravenous or oral Flucloxacillin with a Placebo oral capsule

Intravenous or oral Flucloxacillin with Clindamycin oral capsule

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Decrease in pain
Assessed using a visual analogue score
Quality of life
Assessment based on a questionnaire plus return to work or normal activities and absence of increased side-effects.
Physiological recovery
Resolution of systemic features, composite inflammatory markers and recovery of renal function.

Full Information

First Posted
June 10, 2013
Last Updated
August 16, 2022
Sponsor
University Hospitals Bristol and Weston NHS Foundation Trust
Collaborators
University of Bristol, Public Health England
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1. Study Identification

Unique Protocol Identification Number
NCT01876628
Brief Title
Adjunctive Clindamycin for Cellulitis: C4C Trial.
Acronym
C4C
Official Title
A Double Blind Randomised Control Trial to Measure the Effect of the Addition of Clindamycin to Flucloxacillin for the Treatment of Limb Cellulitis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospitals Bristol and Weston NHS Foundation Trust
Collaborators
University of Bristol, Public Health England

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
Criteria to be used to assess tissue damage and clinical response: Fever, tachycardia, neutrophil count, urea and other laboratory parameters at five and ten days post first dose of clindamycin Limb swelling (by the measurement of limb circumference), skin surface temperature and tissue damage (by the proportion of the limb affected) Document the duration between initial systemic features and the development of local signs Examine the effect of the duration between systemic and local features and first dose of flucloxacillin on the subsequent duration and severity of cellulitis Examine the effect of duration between the first dose of flucloxacillin and the first dose of clindamycin on the subsequent duration and severity of cellulitis Identify and quantify possible side effects of clindamycin

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cellulitis
Keywords
Clindamycin, Cellulitis, Flucloxacillin, Group A streptococcus, Staphylococcus aureus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
410 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Flucloxacillin and Placebo oral capsule
Arm Type
Placebo Comparator
Arm Description
Intravenous or oral Flucloxacillin with a Placebo oral capsule
Arm Title
Flucloxacillin and Clindamycin
Arm Type
Active Comparator
Arm Description
Intravenous or oral Flucloxacillin with Clindamycin oral capsule
Intervention Type
Drug
Intervention Name(s)
Flucloxacillin
Other Intervention Name(s)
Floxapen, Fluclomix, Ladropen
Intervention Description
Intravenous or oral Flucloxacillin. Minimum dose 500mg four times each day. Target duration 5 days less pre-recruitment beta-lactam duration.
Intervention Type
Drug
Intervention Name(s)
Clindamycin
Other Intervention Name(s)
Dalacin C, Daclin, Cleocin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Intervention Description
Placebo is externally identical to the over-encapsulated clindamycin and is taken four times each day for 2 days
Primary Outcome Measure Information:
Title
Improvement based on a composite of systemic and local features
Description
Temperature less than 37.5 degrees centigrade, reduction in limb swelling and reduction in skin temperature
Time Frame
Day 5
Secondary Outcome Measure Information:
Title
Decrease in pain
Description
Assessed using a visual analogue score
Time Frame
Day 10
Title
Quality of life
Description
Assessment based on a questionnaire plus return to work or normal activities and absence of increased side-effects.
Time Frame
Day 30
Title
Physiological recovery
Description
Resolution of systemic features, composite inflammatory markers and recovery of renal function.
Time Frame
Day 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 Exclusion Criteria: Patients with a confirmed history of penicillin, flucloxacillin or clindamycin allergy Patients known to be colonised with Methicillin-resistant Staphylococcus aureus or Methicillin-resistant Staphylococcus aureus isolated from wound within the last year Patients 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 Pre-existing diarrhoea
Facility Information:
Facility Name
University Hospitals Bristol NHS Foundation Trust
City
Bristol
ZIP/Postal Code
BS2 8HW
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
28314743
Citation
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.
Results Reference
derived

Learn more about this trial

Adjunctive Clindamycin for Cellulitis: C4C Trial.

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