Penicillin for the Emergency Department Outpatient Treatment of CELLulitis

Summary

The main objective of this study is to investigate the non-inferiority of oral flucloxacillin alone compared with a combination of oral flucloxacillin and phenoxymethylpenicillin for the emergency department directed outpatient treatment of cellulitis, wound infections and abscesses, recently renamed by the Food and Drug Administration (FDA) as acute bacterial skin and skin structure infections (ABSSSIs). Half of the trial participants will receive flucloxacillin and placebo in combination, and the remaining half will be treated will flucloxacillin and phenoxymethylpenicillin.

In a secondary objective the trial aims to measure adherence and persistence of trial patients with outpatient antibiotic therapy. In addition a within-trial evaluation of the cost per quality adjusted life year (QALY) gained from the use of oral flucloxacillin compared with combination therapy from the perspective of the health-care payer (direct costs) the patient and government. Finally the study will externally validate the Extremity Soft Tissue Infection-score, a Health Related Quality of Life (HRQL) questionnaire designed to quantify the impact of cellulitis, wound infections and abscesses on patient HRQL in clinical trials.

Conditions

• Cellulitis
• Wound Infection
• Abscess

Interventions

DRUG

Flucloxacillin

One flucloxacillin capsule of 500mg strength taken four times daily for 7 days

DRUG

Phenoxymethylpenicillin

One capsule of phenoxymethylpenicillin of 500 mg strength taken four times daily for 7 days

DRUG

Placebo (for phenoxymethylpenicillin)

Over-encapsulation of phenoxymethylpenicillin will be performed by the manufacturer of the investigational medicinal products such that placebo and active phenoxymethylpenicillin are identical in size, shape, colour and smell, and are packaged in identical bottles

Sponsors & Collaborators

• Health Research Board, Ireland

  collaborator OTHER

• Royal College of Surgeons, Ireland

  lead OTHER

Principal Investigators

• Adrian Moughty · Mater Misericordiae University Hospital

• Joseph McKeever · Connolly Hospital Blanchardstown

• Conor Deasy · Department of Emergency Medicine, Cork University Hopsital, Cork

• Chris Luke · Department of Emergency Medicine, Mercy University, Cork

• Abel Wakai, MD FRCEM · Department of Emergency Medicine, Beaumont Hospital, Dublin

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

16 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-12-31

Primary Completion

2019-12-31

Completion

2019-12-31

Countries

• Ireland

Study Locations