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ISRCTN
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ISRCTN03813200
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ClinicalTrials.gov identifier
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Public title
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Randomised controlled trial to investigate whether prophylactic antibiotics can prevent further episodes of cellulitis (erysipelas) of the leg (PATCH II)
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Scientific title
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Acronym
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PATCH II - Prophylactic Antibiotics for the Treatment of Cellulitis at Home II
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Serial number at source
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26083
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Study hypothesis
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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.
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Ethics approval
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Approved by the Nottingham Research Ethics Committee (2) on the 27th March 2006.
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Study design
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Multi-centre double-blind randomised controlled trial
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Countries of recruitment
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Ireland, United Kingdom
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Disease/condition/study domain
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Cellulitis of the leg
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Participants - inclusion criteria
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Cellulitis of the leg
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Participants - exclusion criteria
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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
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Anticipated start date
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01/01/2007
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Anticipated end date
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31/12/2010
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Status of trial
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Stopped |
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Patient information material
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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
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Target number of participants
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400
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Interventions
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Penicillin VK 250 mg orally twice a day (b.d.) or placebo (b.d.) for 6 months.
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Primary outcome measure(s)
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Time to next episode of cellulitis. Follow-up duration for primary endpoint: up to 3 years depending on date of recruitment into the trial.
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Secondary outcome measure(s)
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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.
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Sources of funding
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The BUPA Foundation (UK)
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Trial website
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http://www.patchtrial.co.uk
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Publications
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2010 discussion of recruitment issues in http://www.ncbi.nlm.nih.gov/pubmed/20196846
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Contact name
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Prof
Hywel
Williams
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Address
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Department of Dermatology
South Block
Queens Medical Centre
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City/town
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Nottingham
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Zip/Postcode
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NG7 2UH
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Country
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United Kingdom
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Sponsor
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University of Nottingham (UK)
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Address
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Research Innovation Services
King's Meadow Campus
University of Nottingham
Lenton lane
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City/town
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Nottingham
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Zip/Postcode
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NG7 2NR
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Country
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United Kingdom
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Date applied
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11/10/2007
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Last edited
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04/05/2010
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Date ISRCTN assigned
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06/12/2007
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