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 |
| Secondary identifying numbers | N0013101031 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 23/09/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Ms Penelope Shirlaw
Scientific
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 |
|---|---|
| pepe.shirlaw@gstt.sthames.nhs.uk |
Study information
| Study design | Randomised double-blind placebo controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| 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(s) | Received from local medical ethics committee |
| 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 |
| Primary outcome measure | 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 study start date | 01/10/2001 |
| Overall study end date | 01/04/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 81 (intervention group: 41, control group:40) |
| 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 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
- England
- United Kingdom
Study participating centre
Oral Medicine Department
London
SE1 9RT
United Kingdom
SE1 9RT
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Hospital/treatment centre
Guy's and St Thomas' NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2005 | Yes | No |
