RCT to Investigate if Prophylactic Antibiotics Prevent Further Episodes of Cellulitis (Erysipelas) of the Leg
- Conditions
- Cellulitis/Erysipelas of the Leg
- Interventions
- Drug: Penicillin VKOther: placebo
- Registration Number
- NCT00552799
- Lead Sponsor
- University of Nottingham
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 274
- Diagnosis of cellulitis of either leg AND a history of at least one previous episode of cellulitis of either leg within the three
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.
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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.
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Known allergy to penicillin.
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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.
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Unable to give informed consent.
-
Already taking part in a research study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Penicillin VK Penicillin VK 250 mg b.d. 2 placebo placebo tablet b.d.
- Primary Outcome Measures
Name Time Method The primary outcome is time to next episode of cellulitis variable
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (25)
South Infirmary-Victoria University Hospital
🇮🇪Cork, Ireland
York Hospital
🇬🇧York, United Kingdom
Queens Medical Centre
🇬🇧Nottingham, Nottinghamshire, United Kingdom
Princess Royal Hospital
🇬🇧Hull, United Kingdom
Queen Elizabeth Hospital
🇬🇧King's Lynn, United Kingdom
Leicester Royal Infirmary
🇬🇧Leicester, United Kingdom
Hope Hospital
🇬🇧Salford, United Kingdom
Ipswich Hospital
🇬🇧Ipswich, United Kingdom
Broadgreen Hospital
🇬🇧Liverpool, United Kingdom
Royal Berkshire Hospital
🇬🇧Reading, United Kingdom
Singleton Hospital
🇬🇧Swansea, United Kingdom
King's Mill Hospital
🇬🇧Sutton in Ashfield, 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
Amersham Hospital
🇬🇧Amersham, United Kingdom
Gloucestershire Royal Infirmary
🇬🇧Gloucester, United Kingdom
Aberdeen Royal Infirmary
🇬🇧Aberdeen, United Kingdom
University Hospital of North Durham
🇬🇧Durham, United Kingdom
James Paget University Hospital
🇬🇧Great Yarmouth, United Kingdom
Norfolk and Norwich University Hospital
🇬🇧Norwich, United Kingdom
Altnagelvin Area Hospital
🇬🇧Londonderry, United Kingdom
Royal Victoria Infirmary
🇬🇧Newcastle upon Tyne, United Kingdom
Watford General Hospital
🇬🇧Watford, United Kingdom