Randomised controlled trial of the efficacy of adding intravenous benzylpenicillin to intravenous flucloxacillin in the treatment of lower limb cellulitis

ISRCTN	ISRCTN18890135
DOI	https://doi.org/10.1186/ISRCTN18890135
Protocol serial number	N0013101031
Sponsor	Department of Health
Funder	Guy's and St Thomas' NHS Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Ms Penelope Shirlaw
Scientific

Oral Medicine Department
22nd Floor, Guy's Tower
Guy's Hospital
St Thomas Street
London
SE1 9RT
United Kingdom

Phone	+44 (0)20 7188 4399
Email	pepe.shirlaw@gstt.sthames.nhs.uk

Primary study design	Interventional
Study design	Randomised double-blind placebo controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Does the addition of benzylpenicillin shorten the duration of stay of patients and/or decrease the number of beta-lactam therapy failures. Please note that as of 23/09/09 inclusion and exclusion criteria for this trial have been updated.
Ethics approval(s)	Received from local medical ethics committee
Health condition(s) or problem(s) studied	Cellulitis
Intervention	In non-penicillin allergic patients, after consent they will be randomised to receive one of 2 treatments: 1. Intravenous (IV) flucloxacillin 1g four times a day (qds) and IV benzylpenicillin 1.2 g qds 2. IV flucloxacillin 1g qds and IV placebo (N Saline) qds.
Intervention type	Other
Primary outcome measure(s)	Duration of stay, as determined by the number of 6 hourly doses of antibiotic the patient received prior to discharge.
Key secondary outcome measure(s)	Therapy failure rate
Completion date	01/04/2003

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	81
Key inclusion criteria	Current information as of 23/09/09: 1. Patients with lower limb cellulitis and who require admission 2. Initial diameter of cellulitis >100 mm 3. Able to understand spoken and written english Initial information at time of registration: Patients with lower limb cellulitis and who require admission
Key exclusion criteria	Added 23/09/09: 1. Known allergy to the study drugs 2. Known renal or hepatic impairment, 3. Random capillary glucose >13 mmol/l 4. Acute co-existent illness in the affected leg, such as deep venous thrombosis, or wound/abscess requiring operative debridement/ repair.
Date of first enrolment	01/10/2001
Date of final enrolment	01/04/2003

Oral Medicine Department

London
SE1 9RT
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2005		Yes	No