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RCT to Investigate if Prophylactic Antibiotics Prevent Further Episodes of Cellulitis (Erysipelas) of the Leg (PATCH I)
This study is currently recruiting participants.
Verified by University of Nottingham, June 2008
Sponsors and Collaborators: University of Nottingham
Action Medical Research
UK Dermatology Clinical Trials Network
Information provided by: University of Nottingham
ClinicalTrials.gov Identifier: NCT00552799
  Purpose

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
Drug Information available for: Penicillins Penicillin V Penicillin V Potassium
U.S. FDA Resources
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)

Further study details as provided by University of Nottingham:

Primary Outcome Measures:
  • The primary outcome is time to next episode of cellulitis [ Time Frame: variable ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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.
Drug: Penicillin VK
Biconcave tablet 250mg oral, b.d.
2: Placebo Comparator
placebo tablet b.d.
Other: placebo
biconcave tablet matching active comparator as much as possible in size and shape

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

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00552799

Contacts
Contact: Katharine Foster, PhD 0115 8468626 patch@nottingham.ac.uk
Contact: Brenda Cooper 0115 8468629 patch@nottingham.ac.uk

Locations
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            
Sponsors and Collaborators
University of Nottingham
Action Medical Research
UK Dermatology Clinical Trials Network
Investigators
Study Director: Hywel Williams, Professor University of Nottingham
  More Information

study website  This link exits the ClinicalTrials.gov site

Responsible Party: University of Nottingham ( Mr Paul Cartledge )
Study ID Numbers: 26083, ISRCTN34716921, EudraCT No. 2006-000381-36
Study 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

Keywords provided by University of Nottingham:
cellulitis
lymphoedema
penicillin
clinical trial

Study placed in the following topic categories:
Bacterial Infections
Penicillin V
Skin Diseases
Inflammation
Lymphedema
Cellulitis
Skin Diseases, Infectious
Gram-Positive Bacterial Infections
Streptococcal Infections
Skin Diseases, Bacterial
Connective Tissue Diseases
Erysipelas
Suppuration

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-Bacterial Agents
Pathologic Processes
Therapeutic Uses
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009