Condition category
Skin and Connective Tissue Diseases
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
23/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Penelope Shirlaw

ORCID ID

Contact details

Oral Medicine Department
22nd Floor
Guy's Tower
Guy's Hospital
St Thomas Street
London
SE1 9RT
United Kingdom
+44 (0)20 7188 4399
pepe.shirlaw@gstt.sthames.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0013101031

Study information

Scientific title

Acronym

Study hypothesis

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

Received from local medical ethics committee

Study design

Randomised double-blind placebo controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

Duration of stay, as determined by the number of 6 hourly doses of antibiotic the patient received prior to discharge.

Secondary outcome measures

Therapy failure rate

Overall trial start date

01/10/2001

Overall trial end date

01/04/2003

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

81 (intervention group: 41, control group:40)

Participant 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.

Recruitment start date

01/10/2001

Recruitment end date

01/04/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Oral Medicine Department
London
SE1 9RT
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Funder name

Guy's and St Thomas' NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2005 results in http://www.ncbi.nlm.nih.gov/pubmed/15843702

Publication citations

  1. Results

    Leman P, Mukherjee D, Flucloxacillin alone or combined with benzylpenicillin to treat lower limb cellulitis: a randomised controlled trial., Emerg Med J, 2005, 22, 5, 342-346, doi: 10.1136/emj.2004.019869.

Additional files

Editorial Notes