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

Study website

Contact information

Prof Hywel Williams
Scientific

Department of Dermatology
South Block
Queens Medical Centre
Nottingham
NG7 2UH
United Kingdom

Study information

Study designMulti-centre double-blind randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typePrevention
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 titleA randomised controlled trial of phrophylactic antibiotics for the prevention of recurrent cellulitis (erysipelas) of the leg (PATCH II)
Study acronymPATCH II - Prophylactic Antibiotics for the Treatment of Cellulitis at Home II
Study objectivesTo 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) studiedCellulitis of the leg
InterventionPenicillin VK 250 mg orally twice a day (b.d.) or placebo (b.d.) for 6 months.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Penicillin
Primary outcome measureTime 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 measures1. 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 date01/01/2007
Completion date31/12/2010
Reason abandoned (if study stopped)Participant recruitment issue

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants400
Key inclusion criteriaCellulitis of the leg
Key exclusion criteria1. 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 enrolment01/01/2007
Date of final enrolment31/12/2010

Locations

Countries of recruitment

  • England
  • Ireland
  • United Kingdom

Study participating centre

Department of Dermatology
Nottingham
NG7 2UH
United Kingdom

Sponsor information

University of Nottingham (UK)
University/education

Research Innovation Services
King's Meadow Campus
University of Nottingham
Lenton lane
Nottingham
NG7 2NR
England
United Kingdom

ROR logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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