Adjunctive Clindamycin for Cellulitis: C4C Trial.

NCT ID: NCT01876628

Last Updated: 2022-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 410 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2016-03-31

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:

1. Fever, tachycardia, neutrophil count, urea and other laboratory parameters at five and ten days post first dose of clindamycin

2. Limb swelling (by the measurement of limb circumference), skin surface temperature and tissue damage (by the proportion of the limb affected)

3. Document the duration between initial systemic features and the development of local signs

4. Examine the effect of the duration between systemic and local features and first dose of flucloxacillin on the subsequent duration and severity of cellulitis

5. 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

6. Identify and quantify possible side effects of clindamycin

Conditions

Cellulitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Flucloxacillin and Placebo oral capsule

Intravenous or oral Flucloxacillin with a Placebo oral capsule

Group Type: PLACEBO_COMPARATOR

Flucloxacillin

Intervention Type: DRUG

Intravenous or oral Flucloxacillin. Minimum dose 500mg four times each day. Target duration 5 days less pre-recruitment beta-lactam duration.

Placebo oral capsule

Intervention Type: DRUG

Placebo is externally identical to the over-encapsulated clindamycin and is taken four times each day for 2 days

Flucloxacillin and Clindamycin

Intravenous or oral Flucloxacillin with Clindamycin oral capsule

Group Type: ACTIVE_COMPARATOR

Flucloxacillin

Intervention Type: DRUG

Intravenous or oral Flucloxacillin. Minimum dose 500mg four times each day. Target duration 5 days less pre-recruitment beta-lactam duration.

Clindamycin

Intervention Type: 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.

Interventions

Flucloxacillin

Intravenous or oral Flucloxacillin. Minimum dose 500mg four times each day. Target duration 5 days less pre-recruitment beta-lactam duration.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Placebo oral capsule

Placebo is externally identical to the over-encapsulated clindamycin and is taken four times each day for 2 days

Intervention Type: DRUG

Other Intervention Names

Floxapen; Fluclomix; Ladropen; Dalacin C; Daclin; Cleocin

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Bristol

OTHER

Sponsor Role: collaborator

Public Health England

OTHER_GOV

Sponsor Role: collaborator

University Hospitals Bristol and Weston NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospitals Bristol NHS Foundation Trust

Bristol, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 28314743 (View on PubMed)

Other Identifiers

2013-001218-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

C4C-4078

Identifier Type: -

Identifier Source: org_study_id