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Prophylactic Antibiotics for the Treatment of Cellulitis at Home I
ISRCTN ISRCTN34716921
DOI 10.1186/ISRCTN34716921
ClinicalTrials.gov identifier NCT00552799
EudraCT number 2006-000381-36
Public title Prophylactic Antibiotics for the Treatment of Cellulitis at Home I
Scientific title A randomised controlled trial of prophylactic antibiotics for the prevention of recurrent cellulitis (erysipelas) of the leg (PATCH I)
Acronym PATCH I
Serial number at source SP4063
Study hypothesis To ascertain whether antibiotic prophylaxis (penicillin V) can prevent recurrent cellulitis of the leg.

A pilot/feasibility study was performed prior to this trial, and the results published in 2007: http://www.ncbi.nlm.nih.gov/pubmed/17257411.

Please note that as of 23/09/10, this record has been updated. The end date for this study has been extended from 30/06/09 to 31/10/11.
Lay summary http://www.ctu.mrc.ac.uk/research_areas/study_details.aspx?s=90
Ethics approval Nottingham Research Ethics Committee (2) on 27/03/2006
Study design Multi-centre double-blind randomised controlled trial
Countries of recruitment Ireland, United Kingdom
Disease/condition/study domain Recurrent cellulitis of the leg
Participants - inclusion criteria 1. Aged over 16 years - no upper age limit, either sex
2. At least one previous episode of cellulitis of either leg within the three years prior to the current acute index episode of cellulitis.
Participants - exclusion criteria Added 09/01/2009:
Any doubt about the certainty of the diagnosis of either the index episode or the previous episode (if applicable), will be grounds for exclusion. Additionally, patients with any of the following will be excluded:
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, as these cases are more likely to be caused by staphylococcal infection. (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. This includes, but is not limited to:
5.1. The treating physician and/or patient feels that prophylactic antibiotics are not in the patient's best interests and therefore entry to this study would be inappropriate
5.2. The treating physician and/or patient feels it would not be ethical or appropriate for the patient to receive placebo and so they are not willing/able to accept randomisation
5.3. Concomitant medication that would mean that long-term penicillin is inappropriate
5.4. Diagnostic uncertainty
5.5. Gastrointestinal disease causing persistent diarrhoea or vomiting severe enough to affect the absorption of the phenoxymethylpenicillin
5.6. Allergic diathesis or severe bronchial asthma severe enough to preclude the use of phenoxymethylpenicillin
5.7. Confounding concurrent disease (e.g. deep vein thrombosis [DVT])
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
Anticipated start date 01/06/2006
Anticipated end date 31/10/2011
Status of trial Completed
Patient information material Can be found on www.patchtrial.co.uk
Target number of participants 260
Interventions The anticipated end date of this trial has been amended from 30/06/2007 to 30/06/2009 as of 15/11/2007. This is due to the incorrect date provided at time of registration and does not reflect a change in the initial trial schedule.

Active group: penicillin V 250 mg twice a day (bd) for 12 months
Inactive group: placebo bd for 12 months
Primary outcome measure(s) Time to next episode of cellulites.

Amended 23/09/10
Follow-up duration for primary endpoints 24 months depending on date of recruitment into trial (Duration of follow up was expected to be 12-18 months, at the time of registration)
Secondary outcome measure(s) 1. Proportion of participants with repeat episodes of cellulitis
2. Proportion of participants with oedema and/or ulceration
3. Number of days in hospital for the treatment of repeat episodes of cellulitis
4. Number of adverse drug reactions reported in each treatment arm
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]).

The time point for each outcome measure will vary with each individual participant but overall they will all be measures throughout the study period which is up to three years from randomisation.
Sources of funding Action Medical Research (UK)
Trial website http://www.patchtrial.co.uk
Publications 1. 2006 protocol in Journal of Lymphoedema, Vol 1, No 1. 34 - 37
2. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23635049
Contact name Dr  Kim  Thomas
  Address Centre of Evidence-Based Dermatology
University of Nottingham
King's Meadow Campus
  City/town Nottingham
  Zip/Postcode NG7 2NR
  Country United Kingdom
  Tel +44 (0)115 846 8632
  Email kim.thomas@nottingham.ac.uk
Sponsor University of Nottingham (UK)
  Address University Park
  City/town Nottingham
  Zip/Postcode NG7 2RD
  Country United Kingdom
  Email kim.thomas@nottingham.ac.uk
  Sponsor website: http://www.nottingham.ac.uk
Date applied 21/11/2005
Last edited 03/05/2013
Date ISRCTN assigned 04/05/2006
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