Randomised controlled trial to investigate whether prophylactic antibiotics can prevent further episodes of cellulitis (erysipelas) of the leg (PATCH II)
| ISRCTN | ISRCTN03813200 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN03813200 |
| Secondary identifying numbers | 26083 |
- Submission date
- 11/10/2007
- Registration date
- 06/12/2007
- Last edited
- 01/05/2012
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Skin and Connective Tissue Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
http://www.ctu.mrc.ac.uk/research_areas/study_details.aspx?s=90
Contact information
Prof Hywel Williams
Scientific
Scientific
Department of Dermatology
South Block
Queens Medical Centre
Nottingham
NG7 2UH
United Kingdom
Study information
| Study design | Multi-centre double-blind randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| Participant information sheet | For both PATCH I and PATCH II: Full version: http://ctsu.nottingham.ac.uk/ts0601/docs/Participant%20Information%20Sheet%20v1%203.doc Short version: http://ctsu.nottingham.ac.uk/ts0601/docs/Short%20Participant%20information%20sheet%20v1%200.doc Information can also be found at: www.patchtrial.co.uk |
| Scientific title | A randomised controlled trial of phrophylactic antibiotics for the prevention of recurrent cellulitis (erysipelas) of the leg (PATCH II) |
| Study acronym | PATCH II - Prophylactic Antibiotics for the Treatment of Cellulitis at Home II |
| Study objectives | To assess whether a period of six months of prophylactic penicillin after an episode of cellulitis of the leg reduces the risk of repeat episodes. |
| Ethics approval(s) | Nottingham Research Ethics Committee (2) on 27/03/2006 |
| Health condition(s) or problem(s) studied | Cellulitis of the leg |
| Intervention | Penicillin VK 250 mg orally twice a day (b.d.) or placebo (b.d.) for 6 months. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Penicillin |
| Primary outcome measure | Time to next episode of cellulitis. Follow-up duration for primary endpoint: up to 3 years depending on date of recruitment into the trial. |
| Secondary outcome measures | 1. Proportion of participants with repeat episodes of cellulitis in the active treatment arm compared with the placebo treatment arm at the end of the treatment phase, and at the end of the non-intervention follow-up phase 2. Proportion of participants with oedema and/or ulceration in the active treatment arm compared with the placebo treatment arm at the end of the treatment phase, and at the end of the non-intervention follow-up phase 3. Number of nights in hospital for the treatment of repeat episodes of cellulitis. Duration of follow-up: up to 3 years depending on date of recruitment into the trial. 4. Number of adverse drug reactions reported in each treatment arm. Duration of follow-up: up to 3 years depending on date of recruitment into the trial. 5. Cost-effectiveness, including GP consultations, prescriptions for antibiotics and days in hospital 6. Predictors of response multiple regression model to explore the impact of known risk factors in predicting the efficacy of prophylaxis 7. Impact of cellulitis on health-related quality of life, assessed using the EuroQol (EQ-5D) and also a measure specific to dermatology (the Dermatology Life Quality Index [DLQI]). These will be measured at baseline (i.e. during the index episode of cellulitis) and at 10 days. The same measures will also be taken during any repeat episodes of cellulitis. |
| Overall study start date | 01/01/2007 |
| Completion date | 31/12/2010 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 400 |
| Key inclusion criteria | Cellulitis of the leg |
| Key exclusion criteria | 1. Taken antibiotic prophylaxis (defined as more than 3 months usage) for the prevention of cellulitis within 6 months prior to index episode 2. A time lapse of longer than 12 weeks since the start of treatment for the index episode to the date of potential randomisation into the trial 3. Known allergy to penicillin 4. Preceding leg ulceration, surgery or penetrating trauma (NB: this does not exclude patients with toeweb maceration/tinea pedis or other minor/blunt wounds) 5. Treating physician or principal investigator unwilling to randomise patient 6. No access to a telephone 7. Aged less than 16 years 8. Unable to give informed consent 9. Already taking part in a research study |
| Date of first enrolment | 01/01/2007 |
| Date of final enrolment | 31/12/2010 |
Locations
Countries of recruitment
- England
- Ireland
- United Kingdom
Study participating centre
Department of Dermatology
Nottingham
NG7 2UH
United Kingdom
NG7 2UH
United Kingdom
Sponsor information
University of Nottingham (UK)
University/education
University/education
Research Innovation Services
King's Meadow Campus
University of Nottingham
Lenton lane
Nottingham
NG7 2NR
England
United Kingdom
"ROR" |
https://ror.org/01ee9ar58 |
|---|
Funders
Funder type
Charity
The BUPA Foundation (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? |
|---|---|---|---|---|---|
| Other publications | discussion of recruitment issues | 02/03/2010 | Yes | No | |
| Results article | results | 01/01/2012 | Yes | No |
