Comparison between one antibiotic (flucloxacillin) and two antibiotics (flucloxacillin and clindamycin) for the treatment of skin infections (cellulitis).

Phase 1

• Conditions: Cellulitis; MedDRA version: 16.0Level: PTClassification code 10007882Term: CellulitisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2013-001218-14-GB
• Lead Sponsor: niversity Hospitals Bristol NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-03
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 450

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

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

Exclusion Criteria

Patients with a confirmed history of penicillin, flucloxacillin or clindamycin allergy.
Patients known to be colonised with MRSA or MRSA isolated from wound within the last year.
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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified