Adjunctive Clindamycin for Cellulitis: C4C Trial.

University Hospitals Bristol and Weston NHS Foundation Trust

Status and phase: Completed; Phase 4

Conditions: Cellulitis

Treatments: Drug: Clindamycin; Drug: Placebo oral capsule; Drug: Flucloxacillin

Study type: Interventional

Funder types: Other

Identifiers

NCT01876628

C4C-4078

2013-001218-14 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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

Enrollment: 410 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

410 participants in 2 patient groups, including a placebo group

Flucloxacillin and Placebo oral capsule

Placebo Comparator group

Description:

Intravenous or oral Flucloxacillin with a Placebo oral capsule

Treatment:

Drug: Flucloxacillin

Drug: Placebo oral capsule

Flucloxacillin and Clindamycin

Active Comparator group

Description:

Intravenous or oral Flucloxacillin with Clindamycin oral capsule

Treatment:

Drug: Flucloxacillin

Drug: Clindamycin