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RCT to Investigate if Prophylactic Antibiotics Prevent Further Episodes of Cellulitis (Erysipelas) of the Leg

Information source: University of Nottingham
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cellulitis/Erysipelas of the Leg

Intervention: Penicillin VK (Drug); placebo (Other)

Phase: Phase 4

Status: Completed

Sponsored by: University of Nottingham

Official(s) and/or principal investigator(s):
Hywel Williams, Professor, Study Director, Affiliation: University of Nottingham


To assess whether a period of prophylactic penicillin after an episode of cellulitis of the leg reduces the risk of repeat episodes. Participants are randomised to receive 12 months of prophylaxis (penicillin VK 250mg b. d. or placebo). The PATCH I study will recruit only patients with recurrent disease.

Clinical Details

Official title: Randomised Controlled Trial to Investigate Whether Prophylactic Antibiotics Can Prevent Further Episodes of Cellulitis (Erysipelas) of the Leg (PATCH I)

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: The primary outcome is time to next episode of cellulitis

Secondary outcome: Secondary outcomes include: i) the proportion of participants with repeat episodes of cellulitis; ii) proportion of participants with oedema and/or ulceration; iii) cost-effectiveness; iv) predictors of response (multiple regression model).

Detailed description: Cellulitis of the leg is an common, acute, painful and potentially serious infection of the skin and subcutaneous tissue. It currently accounts for 2-3% of UK hospital admissions. The average length of in-patient stay is 9 days (Hospital Episode Statistics, Department of Health (UK), 2002-2003) and 25-50% of treated patients suffer further episodes and other morbidity, such as oedema and ulceration. Cellulitis of the lower leg is usually due to streptococcal infection that has entered into the body via a relatively subtle portal, such as toeweb fissures. Penicillin is the most useful of the commonly used oral antibiotics against streptococci, although other agents such as flucloxacillin are often used if staphylococcal infection is a clinical possibility. There are numerous risk factors for cellulitis of the lower leg and recurrent disease is one the biggest problems. Existing evidence for the use of prophylactic antibiotics to prevent further episodes is very limited. Two small randomised controlled trials (RCTs) hint at possible benefit, but these studies are very small (16 and 40 participants respectively). Despite this, many physicians routinely use prophylactic antibiotics for recurrent cellulitis, although opinions on the value of such practice is firmly divided. This study will recruit over a 12-24 month period participants who have completed the therapy for the current episode of cellulitis. Participants will be followed up for up to 24 months with telephone calls at 10 days, 3 months, 6 months, 9 months and 12 months and then every 6 months after completing the intervention. A diary will also be provided as an "aid memoir" to phone calls and to note missed tablets and recurrence of cellulitis.


Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Diagnosis of cellulitis of either leg AND a history of at least one previous episode

of cellulitis of either leg within the three Exclusion Criteria: 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:

- Taken antibiotic prophylaxis (defined as more than 3 months usage) for the prevention

of cellulitis within 6 months prior to index episode.

- 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.

- Known allergy to penicillin.

- 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).

- Treating physician or principal investigator unwilling to randomise patient. This

includes, but is not limited to:

- 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.

- 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

- Concomitant medication that would mean that long-term penicillin is


- Diagnostic uncertainty

- Gastrointestinal disease causing persistent diarrhoea or vomiting severe enough

to affect the absorption of the phenoxymethylpenicillin.

- Allergic diathesis or severe bronchial asthma severe enough to preclude the use

of phenoxymethylpenicillin.

- Confounding concurrent disease (e. g. DVT).

- No access to a telephone.

- Aged less than 16 years.

- Unable to give informed consent.

- Already taking part in a research study.

Locations and Contacts

South Infirmary-Victoria University Hospital, Cork, Ireland

Aberdeen Royal Infirmary, Aberdeen AB25 2ZN, United Kingdom

Amersham Hospital, Amersham HP7 0JD, United Kingdom

Brighton General Hospital, Brighton BN2 3EW, United Kingdom

Bristol Royal Infirmary, Bristol BS2 8HW, United Kingdom

Cumberland Infirmary, Carlisle CA2 7HY, United Kingdom

Derbyshire Royal Infirmary, Derby DE1 2QY, United Kingdom

University Hospital of North Durham, Durham DE1 5TW, United Kingdom

Gloucestershire Royal Infirmary, Gloucester GL1 3NN, United Kingdom

James Paget University Hospital, Great Yarmouth NR31 6LA, United Kingdom

Princess Royal Hospital, Hull HU8 9HE, United Kingdom

Ipswich Hospital, Ipswich IP4 5HD, United Kingdom

Queen Elizabeth Hospital, King's Lynn PE30 4ET, United Kingdom

Leicester Royal Infirmary, Leicester LE1 5WW, United Kingdom

Broadgreen Hospital, Liverpool L14 3LB, United Kingdom

Altnagelvin Area Hospital, Londonderry BT47 6SB, United Kingdom

Royal Victoria Infirmary, Newcastle upon Tyne NE1 4LP, United Kingdom

Norfolk and Norwich University Hospital, Norwich NR4 7UY, United Kingdom

Royal Berkshire Hospital, Reading RG1 5AN, United Kingdom

Hope Hospital, Salford M6 8HD, United Kingdom

King's Mill Hospital, Sutton in Ashfield NG17 4JL, United Kingdom

Singleton Hospital, Swansea SA2 8QA, United Kingdom

Watford General Hospital, Watford WD1 8HB, United Kingdom

York Hospital, York YO31 8HR, United Kingdom

Queens Medical Centre, Nottingham, Nottinghamshire NG7 2UH, United Kingdom

Additional Information

study website

Starting date: July 2006
Last updated: July 23, 2012

Page last updated: August 23, 2015

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