Prophylactic Antibiotics for the Treatment of Cellulitis at Home I

ISRCTN	ISRCTN34716921
DOI	https://doi.org/10.1186/ISRCTN34716921
ClinicalTrials.gov (NCT)	NCT00552799
Clinical Trials Information System (CTIS)	2006-000381-36
Protocol serial number	SP4063
Sponsor	University of Nottingham (UK)
Funder	Action Medical Research (UK)

Submission date: 21/11/2005
Registration date: 04/05/2006
Last edited: 03/05/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Skin and Connective Tissue Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://www.ctu.mrc.ac.uk/research_areas/study_details.aspx?s=90

Contact information

Dr Kim Thomas
Scientific

Centre of Evidence-Based Dermatology
University of Nottingham
King's Meadow Campus
Nottingham
NG7 2NR
United Kingdom

Phone	+44 (0)115 846 8632
Email	kim.thomas@nottingham.ac.uk

Study information

Primary study design	Interventional
Study design	Multi-centre double-blind randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A randomised controlled trial of prophylactic antibiotics for the prevention of recurrent cellulitis (erysipelas) of the leg (PATCH I)
Study acronym	PATCH I
Study objectives	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(s)	Nottingham Research Ethics Committee (2) on 27/03/2006
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Penicillin
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)
Key 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.
Completion date	31/10/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	260
Key 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.
Key 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
Date of first enrolment	01/06/2006
Date of final enrolment	31/10/2011

Locations

Countries of recruitment

United Kingdom
England
Ireland

Study participating centre

Centre of Evidence-Based Dermatology

Nottingham
NG7 2NR
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	02/05/2013		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes