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Sponsors and Collaborators: |
University of Nottingham Action Medical Research UK Dermatology Clinical Trials Network |
Information provided by: | University of Nottingham |
ClinicalTrials.gov Identifier: | NCT00552799 |
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.
Condition | Intervention | Phase |
Cellulitis/Erysipelas of the Leg |
Drug: Penicillin VK Other: placebo |
Phase IV |
Genetics Home Reference related topics: | lymphedema-distichiasis syndrome |
MedlinePlus related topics: | Antibiotics Cellulitis |
ChemIDplus related topics: | Penicillins Penicillin V Penicillin V Potassium |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Randomised Controlled Trial to Investigate Whether Prophylactic Antibiotics Can Prevent Further Episodes of Cellulitis (Erysipelas) of the Leg (PATCH I) |
Estimated Enrollment: | 260 |
Study Start Date: | July 2006 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
Penicillin VK 250 mg b.d.
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Drug: Penicillin VK
Biconcave tablet 250mg oral, b.d.
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2: Placebo Comparator
placebo tablet b.d.
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Other: placebo
biconcave tablet matching active comparator as much as possible in size and shape
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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.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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:
Treating physician or principal investigator unwilling to randomise patient. This includes, but is not limited to:
Contact: Katharine Foster, PhD | 0115 8468626 | patch@nottingham.ac.uk |
Contact: Brenda Cooper | 0115 8468629 | patch@nottingham.ac.uk |
Ireland | |||||
South Infirmary-Victoria University Hospital | Recruiting | ||||
Cork, Ireland | |||||
Contact: John Bourke | |||||
Principal Investigator: John Bourke | |||||
United Kingdom | |||||
Royal Victoria Infirmary | Recruiting | ||||
Newcastle upon Tyne, United Kingdom, NE1 4LP | |||||
Contact: Simon Meggitt | |||||
Principal Investigator: Simon Meggitt | |||||
University Hospital of North Durham | Recruiting | ||||
Durham, United Kingdom, DE1 5TW | |||||
Contact: Mary Carr | |||||
Principal Investigator: Mary Carr | |||||
Aberdeen Royal Infirmary | Recruiting | ||||
Aberdeen, United Kingdom, AB25 2ZN | |||||
Contact: Tony Ormerod | |||||
Principal Investigator: Tony Ormerod | |||||
Altnagelvin Area Hospital | Recruiting | ||||
Londonderry, United Kingdom, BT47 6SB | |||||
Contact: Raymond Fulton | |||||
Principal Investigator: Raymond Fulton | |||||
Amersham Hospital | Recruiting | ||||
Amersham, United Kingdom, HP7 0JD | |||||
Contact: John Wilkinson | |||||
Principal Investigator: John Wilkinson | |||||
Ipswich Hospital | Recruiting | ||||
Ipswich, United Kingdom, IP4 5HD | |||||
Contact: Sam Gibbs | |||||
Principal Investigator: Sam Gibbs | |||||
Bristol Royal Infirmary | Recruiting | ||||
Bristol, United Kingdom, BS2 8HW | |||||
Contact: David De Berker | |||||
Principal Investigator: David De Berker | |||||
Broadgreen Hospital | Recruiting | ||||
Liverpool, United Kingdom, L14 3LB | |||||
Contact: Hazel Bell | |||||
Principal Investigator: Hazel Bell | |||||
Cumberland Infirmary | Recruiting | ||||
Carlisle, United Kingdom, CA2 7HY | |||||
Contact: Neil Cox | |||||
Principal Investigator: Neil Cox | |||||
Hope Hospital | Recruiting | ||||
Salford, United Kingdom, M6 8HD | |||||
Contact: Christopher Griffiths, Professor | |||||
Principal Investigator: Christopher Griffiths, Professor | |||||
Brighton General Hospital | Recruiting | ||||
Brighton, United Kingdom, BN2 3EW | |||||
Contact: Elizabeth Derrick | |||||
Principal Investigator: Elizabeth Derrick | |||||
James Paget University Hospital | Recruiting | ||||
Great Yarmouth, United Kingdom, NR31 6LA | |||||
Contact: Ingrid Salvary | |||||
Principal Investigator: Ingrid Salvary | |||||
Leicester Royal Infirmary | Recruiting | ||||
Leicester, United Kingdom, LE1 5WW | |||||
Contact: Graham Johnston | |||||
Principal Investigator: Graham Johnston | |||||
Queen Elizabeth Hospital | Recruiting | ||||
King's Lynn, United Kingdom, PE30 4ET | |||||
Contact: Tina Green | |||||
Principal Investigator: Tina Green | |||||
Singleton Hospital | Recruiting | ||||
Swansea, United Kingdom, SA2 8QA | |||||
Contact: Debbie Shipley | |||||
Principal Investigator: Debbie Shipley | |||||
Watford General Hospital | Recruiting | ||||
Watford, United Kingdom, WD1 8HB | |||||
Contact: Michele Murdoch | |||||
Principal Investigator: Michele Murdoch | |||||
Princess Royal Hospital | Recruiting | ||||
Hull, United Kingdom, HU8 9HE | |||||
Contact: Shernaz Walton | |||||
Principal Investigator: Shernaz Walton | |||||
King's Mill Hospital | Recruiting | ||||
Sutton in Ashfield, United Kingdom, NG17 4JL | |||||
Contact: John English | |||||
Principal Investigator: John English | |||||
York Hospital | Recruiting | ||||
York, United Kingdom, YO31 8HR | |||||
Contact: Calum Lyon | |||||
Principal Investigator: Calum Lyon | |||||
Royal Berkshire Hospital | Recruiting | ||||
Reading, United Kingdom, RG1 5AN | |||||
Contact: Ibrahim Nasr | |||||
Principal Investigator: Ibrahim Nasr | |||||
Derbyshire Royal Infirmary | Recruiting | ||||
Derby, United Kingdom, DE1 2QY | |||||
Contact: Adam Ferguson | |||||
Principal Investigator: Adam Ferguson | |||||
Norfolk and Norwich University Hospital | Recruiting | ||||
Norwich, United Kingdom, NR4 7UY | |||||
Contact: Nick Levell | |||||
Principal Investigator: Nick Levell | |||||
Gloucestershire Royal Infirmary | Recruiting | ||||
Gloucester, United Kingdom, GL1 3NN | |||||
Contact: Thomas Millard | |||||
Principal Investigator: Thomas Millard | |||||
United Kingdom, Nottinghamshire | |||||
Queens Medical Centre | Recruiting | ||||
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH | |||||
Contact: John English, MD | |||||
Principal Investigator: John English |
University of Nottingham |
Action Medical Research |
UK Dermatology Clinical Trials Network |
Study Director: | Hywel Williams, Professor | University of Nottingham |
study website 
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Responsible Party: | University of Nottingham ( Mr Paul Cartledge ) |
Study ID Numbers: | 26083, ISRCTN34716921, EudraCT No. 2006-000381-36 |
First Received: | November 1, 2007 |
Last Updated: | June 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00552799 |
Health Authority: | United Kingdom: Research Ethics Committee; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Ireland: Irish Medicines Board; Ireland: Medical Ethics Research Committee |
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