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Adjunctive Clindamycin for Cellulitis: C4C Trial.

U

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:

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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