RCT to Investigate if Prophylactic Antibiotics Prevent Further Episodes of Cellulitis (Erysipelas) of the Leg
Information source: University of Nottingham
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cellulitis/Erysipelas of the Leg
Intervention: Penicillin VK (Drug); placebo (Other)
Phase: Phase 4
Status: Completed
Sponsored by: University of Nottingham Official(s) and/or principal investigator(s): Hywel Williams, Professor, Study Director, Affiliation: University of Nottingham
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.
Clinical Details
Official title: Randomised Controlled Trial to Investigate Whether Prophylactic Antibiotics Can Prevent Further Episodes of Cellulitis (Erysipelas) of the Leg (PATCH I)
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: The primary outcome is time to next episode of cellulitis
Secondary outcome: 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).
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.
Eligibility
Minimum age: 16 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
South Infirmary-Victoria University Hospital, Cork, Ireland
Aberdeen Royal Infirmary, Aberdeen AB25 2ZN, United Kingdom
Amersham Hospital, Amersham HP7 0JD, United Kingdom
Brighton General Hospital, Brighton BN2 3EW, United Kingdom
Bristol Royal Infirmary, Bristol BS2 8HW, United Kingdom
Cumberland Infirmary, Carlisle CA2 7HY, United Kingdom
Derbyshire Royal Infirmary, Derby DE1 2QY, United Kingdom
University Hospital of North Durham, Durham DE1 5TW, United Kingdom
Gloucestershire Royal Infirmary, Gloucester GL1 3NN, United Kingdom
James Paget University Hospital, Great Yarmouth NR31 6LA, United Kingdom
Princess Royal Hospital, Hull HU8 9HE, United Kingdom
Ipswich Hospital, Ipswich IP4 5HD, United Kingdom
Queen Elizabeth Hospital, King's Lynn PE30 4ET, United Kingdom
Leicester Royal Infirmary, Leicester LE1 5WW, United Kingdom
Broadgreen Hospital, Liverpool L14 3LB, United Kingdom
Altnagelvin Area Hospital, Londonderry BT47 6SB, United Kingdom
Royal Victoria Infirmary, Newcastle upon Tyne NE1 4LP, United Kingdom
Norfolk and Norwich University Hospital, Norwich NR4 7UY, United Kingdom
Royal Berkshire Hospital, Reading RG1 5AN, United Kingdom
Hope Hospital, Salford M6 8HD, United Kingdom
King's Mill Hospital, Sutton in Ashfield NG17 4JL, United Kingdom
Singleton Hospital, Swansea SA2 8QA, United Kingdom
Watford General Hospital, Watford WD1 8HB, United Kingdom
York Hospital, York YO31 8HR, United Kingdom
Queens Medical Centre, Nottingham, Nottinghamshire NG7 2UH, United Kingdom
Additional Information
study website
Starting date: July 2006
Last updated: July 23, 2012
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