Condition category
Skin and Connective Tissue Diseases
Date applied
11/10/2007
Date assigned
06/12/2007
Last edited
01/05/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Contact information

Type

Scientific

Primary contact

Prof Hywel Williams

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

26083

Study information

Scientific title

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

Acronym

PATCH II - Prophylactic Antibiotics for the Treatment of Cellulitis at Home II

Study hypothesis

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

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

Not specified

Trial type

Prevention

Patient 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

Condition

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

Phase

Not Specified

Drug names

Penicillin

Primary outcome measures

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 trial start date

01/01/2007

Overall trial end date

31/12/2010

Reason abandoned

Participant recruitment issue

Eligibility

Participant inclusion criteria

Cellulitis of the leg

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

400

Participant 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

Recruitment start date

01/01/2007

Recruitment end date

31/12/2010

Locations

Countries of recruitment

Ireland, United Kingdom

Trial participating centre

Department of Dermatology
Nottingham
NG7 2UH
United Kingdom

Sponsor information

Organisation

University of Nottingham (UK)

Sponsor details

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

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

The BUPA Foundation (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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. 2010 discussion of recruitment issues in http://www.ncbi.nlm.nih.gov/pubmed/20196846
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/21910701

Publication citations

  1. Discussion of recruitment issues

    Thomas KS, , Studying a disease with no home--lessons in trial recruitment from the PATCH II study., Trials, 2010, 11, 22, doi: 10.1186/1745-6215-11-22.

  2. Results

    , Thomas K, Crook A, Foster K, Mason J, Chalmers J, Bourke J, Ferguson A, Level N, Nunn A, Williams H, Prophylactic antibiotics for the prevention of cellulitis (erysipelas) of the leg: results of the UK Dermatology Clinical Trials Network's PATCH II trial., Br. J. Dermatol., 2012, 166, 1, 169-178, doi: 10.1111/j.1365-2133.2011.10586.x.

Additional files

Editorial Notes