RCT to Investigate if Prophylactic Antibiotics Prevent Further Episodes of Cellulitis (Erysipelas) of the Leg (PATCH1)
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.
Cellulitis/Erysipelas of the Leg
Drug: Penicillin VK
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Randomised Controlled Trial to Investigate Whether Prophylactic Antibiotics Can Prevent Further Episodes of Cellulitis (Erysipelas) of the Leg (PATCH I)|
- The primary outcome is time to next episode of cellulitis [ Time Frame: variable ] [ Designated as safety issue: No ]
- 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). [ Time Frame: variable ] [ Designated as safety issue: No ]
|Study Start Date:||July 2006|
|Study Completion Date:||November 2011|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
Penicillin VK 250 mg b.d.
Drug: Penicillin VK
Biconcave tablet 250mg oral, b.d.
Placebo Comparator: 2
placebo tablet b.d.
biconcave tablet matching active comparator as much as possible in size and shape
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.
|South Infirmary-Victoria University Hospital|
|Queens Medical Centre|
|Nottingham, Nottinghamshire, United Kingdom, NG7 2UH|
|Aberdeen Royal Infirmary|
|Aberdeen, United Kingdom, AB25 2ZN|
|Amersham, United Kingdom, HP7 0JD|
|Brighton General Hospital|
|Brighton, United Kingdom, BN2 3EW|
|Bristol Royal Infirmary|
|Bristol, United Kingdom, BS2 8HW|
|Carlisle, United Kingdom, CA2 7HY|
|Derbyshire Royal Infirmary|
|Derby, United Kingdom, DE1 2QY|
|University Hospital of North Durham|
|Durham, United Kingdom, DE1 5TW|
|Gloucestershire Royal Infirmary|
|Gloucester, United Kingdom, GL1 3NN|
|James Paget University Hospital|
|Great Yarmouth, United Kingdom, NR31 6LA|
|Princess Royal Hospital|
|Hull, United Kingdom, HU8 9HE|
|Ipswich, United Kingdom, IP4 5HD|
|Queen Elizabeth Hospital|
|King's Lynn, United Kingdom, PE30 4ET|
|Leicester Royal Infirmary|
|Leicester, United Kingdom, LE1 5WW|
|Liverpool, United Kingdom, L14 3LB|
|Altnagelvin Area Hospital|
|Londonderry, United Kingdom, BT47 6SB|
|Royal Victoria Infirmary|
|Newcastle upon Tyne, United Kingdom, NE1 4LP|
|Norfolk and Norwich University Hospital|
|Norwich, United Kingdom, NR4 7UY|
|Royal Berkshire Hospital|
|Reading, United Kingdom, RG1 5AN|
|Salford, United Kingdom, M6 8HD|
|King's Mill Hospital|
|Sutton in Ashfield, United Kingdom, NG17 4JL|
|Swansea, United Kingdom, SA2 8QA|
|Watford General Hospital|
|Watford, United Kingdom, WD1 8HB|
|York, United Kingdom, YO31 8HR|
|Study Director:||Hywel Williams, Professor||University of Nottingham|