Infection of the skin and subcutaneous tissues (cellulitis) MedDRA version: 9.1 Level: LLT Classification code 10007882 Term: Cellulitis MedDRA version: 9.1 Level: LLT Classification code 10015145 Term: Erysipelas MedDRA version: 9.1 Level: LLT Classification code 10021531 Term: Impetigo MedDRA version: 9.1 Level: LLT Classification code 10000269 Term: Abscess MedDRA version: 9.1 Level: LLT Classification code 10048038 Term: Wound infection MedDRA version: 9.1 Level: LLT Classification cod
Conditions
Interventions
Product Name: Flucloxacillin
Pharmaceutical Form: Capsule*
INN or Proposed INN: FLUCLOXACILLIN
CAS Number: 5250395
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5
Sponsors
Beaumont Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy, tolerability and safety of oral flucloxacillin and phenoxymethylpenicillin with oral flucloxacillin alone in the treatment of uncomplicated skin and skin structure infections. ;Secondary Objective: To profile,where possible, the bacteriological causes of cellulitis in our catchment population.;Primary end point(s): Clinical cure: Signs and symptoms of infection present at enrolment resolved or improved sufficiently such that further antibiotic therapy is deemed unnecessary Clinical failure: Persistent or worsening signs and symptoms, or improvement only after additional antibiotic therapy prescribed Clinical relapse: Initial improvement in signs and symptoms at treatment completion visit followed by worsening or reappearance of signs and symptoms at test of cure visit. | — |
Countries
Ireland
Outcome results
None listed