A comparison of oral flucloxacillin alone with combined oral phenoxymethylpenicillin and flucloxacillin for the treatment of uncomplicated skin and soft tissue infections

• Conditions: Infection of the skin and subcutaneous tissues (cellulitis); MedDRA version: 9.1Level: LLTClassification code 10007882Term: Cellulitis; MedDRA version: 9.1Level: LLTClassification code 10015145Term: Erysipelas; MedDRA version: 9.1Level: LLTClassification code 10021531Term: Impetigo; MedDRA version: 9.1Level: LLTClassification code 10000269Term: Abscess; MedDRA version: 9.1Level: LLTClassification code 10048038Term: Wound infection; MedDRA version: 9.1Level: LLTClassification code 10016936Term: Folliculitis; MedDRA version: 9.1Level: LLTClassification code 10017557Term: Furunculosis

• Registration Number: EUCTR2008-006151-42-IE
• Lead Sponsor: Beaumont Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12-10
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

It is intended to carry out a Phase IV, double blinded, placebo controlled, prospective randomised controlled trial comparing the two treatment arms on patients attending the emergency department of Beaumont Hospital Dublin.
It is intended to obtain written informed consent from each patient before enrolment.
In patient s between the ages of 12 and 16 years of age, it is intended to obtain consent from parent / next of kin.

PATIENTS

Eligible patients will include those aged >12 years of age with uncomplicated skin and / or skin structure infections that can be treated with antibiotics for a period of 7-10 days.
These infections may include, but are not limited to, the following clinical descriptors:
Cellulitis
Erysipelas
Impetigo
Simple Abscess
Wound infection
Furunculosis
Folliculitis

Inclusion criteria
•>12 years of age
•Skin infection +/- skin structure infection that is treatable with oral antibiotic
•Any 2 of the following signs
erythema / warmth / tenderness / swelling / purulent drainage or discharge / regional lymphadenopathy / induration

Women of childbearing potential will be requested to submit a pretrial urinary pregnancy test, and agree to use effective contraception throughout the study.

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

Exclusion Criteria

Exlusion criteria

•Pregnancy
•Lactation
•Chronic skin condition at the site of infection
•Infection involving prosthetic material
•Thermal injury
•Acne vulgaris
•Perirectal abscess / cellulitis (high risk of anaerobic infection)
•Fungal infection of scalp or nail bed
•Suspected bacteraemia
•Infection severe enough to require intravenous antibiotic
•Immunodeficiency
•Significant vascular disease at the site of infection
•Concomitant treatment with oral or parenteral or topical antibiotics at infection site
•Hypersensitivity to penicillin
•Use of any systemic antibiotic within 7 days
•Patients taking systemic corticosteroids at a dose exceeding 15 mg (or equivalent) per day for greater than 7 days

Study & Design

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