Condition category
Skin and Connective Tissue Diseases
Date applied
21/11/2005
Date assigned
04/05/2006
Last edited
03/05/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Kim Thomas

ORCID ID

Contact details

Centre of Evidence-Based Dermatology
University of Nottingham
King's Meadow Campus
Nottingham
NG7 2NR
United Kingdom
+44 (0)115 846 8632
kim.thomas@nottingham.ac.uk

Additional identifiers

EudraCT number

2006-000381-36

ClinicalTrials.gov number

NCT00552799

Protocol/serial number

SP4063

Study information

Scientific title

A randomised controlled trial of prophylactic antibiotics for the prevention of recurrent cellulitis (erysipelas) of the leg (PATCH I)

Acronym

PATCH I

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.

Ethics approval

Nottingham Research Ethics Committee (2) on 27/03/2006

Study design

Multi-centre double-blind randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Can be found on www.patchtrial.co.uk

Condition

Recurrent cellulitis of the leg

Intervention

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

Intervention type

Drug

Phase

Not Specified

Drug names

Penicillin

Primary outcome measures

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 measures

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.

Overall trial start date

01/06/2006

Overall trial end date

31/10/2011

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

260

Participant 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

Recruitment start date

01/06/2006

Recruitment end date

31/10/2011

Locations

Countries of recruitment

Ireland, United Kingdom

Trial participating centre

Centre of Evidence-Based Dermatology
Nottingham
NG7 2NR
United Kingdom

Sponsor information

Organisation

University of Nottingham (UK)

Sponsor details

University Park
Nottingham
NG7 2RD
United Kingdom
kim.thomas@nottingham.ac.uk

Sponsor type

University/education

Website

http://www.nottingham.ac.uk

Funders

Funder type

Charity

Funder name

Action Medical Research (UK)

Alternative name(s)

AMR

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

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

Publication citations

  1. Results

    Thomas KS, Crook AM, Nunn AJ, Foster KA, Mason JM, Chalmers JR, Nasr IS, Brindle RJ, English J, Meredith SK, Reynolds NJ, de Berker D, Mortimer PS, Williams HC, , Penicillin to prevent recurrent leg cellulitis., N. Engl. J. Med., 2013, 368, 18, 1695-1703, doi: 10.1056/NEJMoa1206300.

Additional files

Editorial Notes