RCT to Investigate if Prophylactic Antibiotics Prevent Further Episodes of Cellulitis (Erysipelas) of the Leg
NCT ID: NCT00552799
Last Updated: 2012-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
274 participants
INTERVENTIONAL
2006-07-31
2011-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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1
Penicillin VK 250 mg b.d.
Penicillin VK
Biconcave tablet 250mg oral, b.d.
2
placebo tablet b.d.
placebo
biconcave tablet matching active comparator as much as possible in size and shape
Interventions
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Penicillin VK
Biconcave tablet 250mg oral, b.d.
placebo
biconcave tablet matching active comparator as much as possible in size and shape
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
16 Years
ALL
No
Sponsors
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Action Medical Research
OTHER
UK Dermatology Clinical Trials Network
NETWORK
University of Nottingham
OTHER
Responsible Party
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Principal Investigators
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Hywel Williams, Professor
Role: STUDY_DIRECTOR
University of Nottingham
Locations
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South Infirmary-Victoria University Hospital
Cork, , Ireland
Queens Medical Centre
Nottingham, Nottinghamshire, 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
Kings 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
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, , United Kingdom
Countries
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Other Identifiers
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ISRCTN34716921
Identifier Type: -
Identifier Source: secondary_id
EudraCT No. 2006-000381-36
Identifier Type: -
Identifier Source: secondary_id
06002
Identifier Type: -
Identifier Source: org_study_id