Adjunctive Clindamycin for Cellulitis: C4C Trial. (C4C)

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ClinicalTrials.gov Identifier: NCT01876628

Recruitment Status : Unknown

Verified November 2015 by University Hospitals Bristol and Weston NHS Foundation Trust.
Recruitment status was: Active, not recruiting

First Posted : June 12, 2013

Last Update Posted : January 8, 2016

Sponsor:

Collaborators:

University of Bristol

Public Health England

Information provided by (Responsible Party):

University Hospitals Bristol and Weston NHS Foundation Trust

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.

Condition or disease	Intervention/treatment	Phase
Cellulitis	Drug: Flucloxacillin and Clindamycin Drug: Flucloxacillin and placebo	Phase 4

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

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	450 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
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 Start Date :	October 2013
Actual Primary Completion Date :	December 2015
Estimated Study Completion Date :	January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cellulitis

Drug Information available for: Clindamycin Clindamycin hydrochloride Clindamycin phosphate Clindamycin palmitate hydrochloride Clindamycin palmitate

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Flucloxacillin and placebo Intravenous or oral Flucloxacillin with an oral placebo	Drug: Flucloxacillin and placebo Placebo is externally identical to the over-encapsulated clindamycin and is taken four times each day for 2 days Other Names: Floxapen Fluclomix Ladropen
Active Comparator: Flucloxacillin and Clindamycin Intravenous or oral Flucloxacillin with oral Clindamycin	Drug: Flucloxacillin and Clindamycin 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. Other Names: Floxapen Fluclomix Ladropen Dalacin C Lincocin Daclin

Outcome Measures

Primary Outcome Measures :

Improvement based on a composite of systemic and local features [ Time Frame: Day 5 ]
Temperature less than 37.5 degrees centigrade, reduction in limb swelling and reduction in skin temperature

Secondary Outcome Measures :

Decrease in pain [ Time Frame: Day 10 ]
Assessed using a visual analogue score
Quality of life [ Time Frame: Day 30 ]
Assessment based on a questionnaire plus return to work or normal activities and absence of increased side-effects.
Physiological recovery [ Time Frame: Day 10 ]
Resolution of systemic features, composite inflammatory markers and recovery of renal function.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01876628

Locations

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United Kingdom
University Hospitals Bristol NHS Foundation Trust
Bristol, United Kingdom, BS2 8HW

Sponsors and Collaborators

University Hospitals Bristol and Weston NHS Foundation Trust

University of Bristol

Public Health England

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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Responsible Party:	University Hospitals Bristol and Weston NHS Foundation Trust
ClinicalTrials.gov Identifier:	NCT01876628
Other Study ID Numbers:	C4C-4078 2013-001218-14 ( EudraCT Number )
First Posted:	June 12, 2013 Key Record Dates
Last Update Posted:	January 8, 2016
Last Verified:	November 2015

Keywords provided by University Hospitals Bristol and Weston NHS Foundation Trust:


Clindamycin Cellulitis Flucloxacillin Group A streptococcus Staphylococcus aureus

Additional relevant MeSH terms:

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Cellulitis Skin Diseases, Infectious Infection Suppuration Connective Tissue Diseases Inflammation Pathologic Processes Clindamycin	Clindamycin palmitate Clindamycin phosphate Floxacillin Anti-Bacterial Agents Anti-Infective Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

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