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

Cellulitis/Erysipelas of the Leg Clinical Trial

— PATCH1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00552799
• Other study ID #: 06002
• Secondary ID: ISRCTN34716921Eu
• Status: Completed
• Phase: Phase 4
• First received: November 1, 2007
• Last updated: July 23, 2012
• Start date: July 2006
• Est. completion date: November 2011

Study information

• Verified date: July 2012
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 274
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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 inappropriate

• 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.

Related Conditions & MeSH terms

• Cellulitis
• Cellulitis/Erysipelas of the Leg
• Erysipelas

Intervention

Drug:
• Penicillin VK
Biconcave tablet 250mg oral, b.d.

Other:
• placebo
biconcave tablet matching active comparator as much as possible in size and shape

Locations

Country	Name	City	State
Ireland	South Infirmary-Victoria University Hospital	Cork
United Kingdom	Aberdeen Royal Infirmary	Aberdeen
United Kingdom	Amersham Hospital	Amersham
United Kingdom	Brighton General Hospital	Brighton
United Kingdom	Bristol Royal Infirmary	Bristol
United Kingdom	Cumberland Infirmary	Carlisle
United Kingdom	Derbyshire Royal Infirmary	Derby
United Kingdom	University Hospital of North Durham	Durham
United Kingdom	Gloucestershire Royal Infirmary	Gloucester
United Kingdom	James Paget University Hospital	Great Yarmouth
United Kingdom	Princess Royal Hospital	Hull
United Kingdom	Ipswich Hospital	Ipswich
United Kingdom	Queen Elizabeth Hospital	King's Lynn
United Kingdom	Leicester Royal Infirmary	Leicester
United Kingdom	Broadgreen Hospital	Liverpool
United Kingdom	Altnagelvin Area Hospital	Londonderry
United Kingdom	Royal Victoria Infirmary	Newcastle upon Tyne
United Kingdom	Norfolk and Norwich University Hospital	Norwich
United Kingdom	Queens Medical Centre	Nottingham	Nottinghamshire
United Kingdom	Royal Berkshire Hospital	Reading
United Kingdom	Hope Hospital	Salford
United Kingdom	King's Mill Hospital	Sutton in Ashfield
United Kingdom	Singleton Hospital	Swansea
United Kingdom	Watford General Hospital	Watford
United Kingdom	York Hospital	York

Sponsors (3)

Lead Sponsor	Collaborator
University of Nottingham	Action Medical Research, UK Dermatology Clinical Trials Network

Countries where clinical trial is conducted

Ireland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome is time to next episode of cellulitis		variable
Secondary	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).		variable

External Links

•   study website