PATCH I

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PATCH I PATCH IIRandomised controlled trials
to investigate whether prophylactic antibiotics
can prevent further episodes of cellulitis
(erysipelas) of the leg

• Joanne Chalmers
• Senior Clinical Trials Manager,
• UK DCTN

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This talk will cover

• Why we are doing the PATCH cellulitis trials
• Role of UK Dermatology Clinical Trials Network
• PATCH trial design

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Research question

• Does penicillin (250mg bd) taken after an episode
  of cellulitis of the leg reduce the risk of
  further attacks?

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Why?

• Cellulitis is common 2-3 of hospital
  admissions
• Significant cost to NHS (average admission 9
  days)
• Significant morbidity
• Prophylactic antibiotics for cellulitis sometimes
  prescribed but limited evidence supporting this
  use
• Answers question of importance to clinicians and
  patients
• First trials to be run through the UK DCTN

...the pain is dreadful, when you stand up it
feels as though your veins are being ripped out.
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What is the UK DCTN?

• Aim to conduct independent, high-quality,
  multi-centre clinical trials
• Questions that are important to clinicians and
  patients
• Network has 260 members
• Dermatologists dermatology nurses
• health services researchers
• patients
• PATCH I II are first DCTN trials
• Shift in NHS towards running trials through
  Networks (www.ukcrn.org.uk)

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How does UK DCTN operate?

• Potential research questions submitted by any
  member (vignette)
• Discussed by Steering Group
• If approved, outline proposal developed by
  Steering Group and Co-ordinating Centre
• Full protocol and funding application developed
• Funding bid submitted to external sources

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The PATCH Study

• Non-commercial studies 2 funding bodies
• Action Medical Research
• The BUPA Foundation
• Randomised, double blind, placebo controlled,
  pragmatic study
• 660 patients in total
• PATCH I 260
• PATCH II 400
• Multi-centre study in UK and Ireland (20 centres)
• Managed by Kath Foster at UK DCTN co-ordinating
  centre
• Website www.patchtrial.co.uk

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Timings

• Approvals finalised in April 2006
• Main REC, regulatory (MHRA)
• Site Specific (local REC), RD
• Southern Ireland IMB Ethics
• First patient recruited in July 2006, most sites
  open for recruitment by end of 2006
• Aim to complete recruitment for both studies by
  December 2008
• Recruitment running behind schedule currently

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Primary Objective

• Does prophylaxis reduce the risk of further
  attacks of cellulitis?

• PATCH II
• First episode and recurrent cellulitis
• 6 months treatment

• PATCH I
• Recurrent cellulitis only
• 12 months treatment

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Secondary Objectives

• Does any protection last after the treatment
  ceases?
• Which baseline factors best predict treatment
  success?
• Are there any cost savings for the NHS?
• Are there any specific safety issues with regard
  to using penicillin in this setting?
• What is the impact of cellulitis on
  health-related quality of life?

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Eligibility Criteria

• Reflect clinical practice as far as possible
• Pilot study showed need to keep diagnosis
  criteria as open as possible
• Diagnosis of cellulitis of the leg
• Warmth tenderness/pain
• Erythema
• Swelling of the leg
• Other signs and symptoms are noted
• Criteria 1-3 must be / have been present if
  cellulitis not seen by a dermatologist

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Main Exclusions

• Prophylactic antibiotics in the previous 6 months
• Allergy to penicillin
• Leg ulcer, surgery or penetrating trauma
• Any concomitant medication that would make
  long-term penicillin inappropriate
• More than 12 weeks since the start of treatment
  for the cellulitis

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Enrolling patients

• Dermatologist identifies and screens patient for
  the study
• Co-ordinating centre (CC) will randomise patient
  upon receipt of all Consent form, CRF etc.
• Web-based randomisation (Nottingham CTSU)
• Medication posted directly to patient from
  Pharmacy at Queens Medical Centre, Nottingham
• Patient followed up by telephone from CC
• Recruiting dermatologist see patient again if
  recurrence of cellulitis occurs

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Schedule (following consent)
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In summary

• First UK DCTN trials important question to
  answer
• Trial is as pragmatic as possible, especially
  with regard to eligibility and intervention
• Answer will have direct impact on subsequent
  clinical practice

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Contact Information

• PATCH Study Kath Foster
• PATCH Trial Manager
• email kath.foster_at_nottingham.ac.uk
• Tel [phone]
• UK DCTN Joanne Chalmers
• Senior Trials Manager
• email joanne.chalmers_at_nottingham.ac.uk
• Tel [phone]
• Carron Layfield
• Network Manager
• email carron.layfield_at_nottingham.ac.uk
• Tel [phone]
• Membership form in delegate pack hand to
  Maggie
• Centre of Evidence-based Dermatology
• King's Meadow Campus, University of Nottingham