RCT to Investigate if Prophylactic Antibiotics Prevent Further Episodes of Cellulitis (Erysipelas) of the Leg (PATCH1)

This study has been completed.
Sponsor:
Collaborators:
Action Medical Research
UK Dermatology Clinical Trials Network
Information provided by (Responsible Party):
University of Nottingham
ClinicalTrials.gov Identifier:
NCT00552799
First received: November 1, 2007
Last updated: July 23, 2012
Last verified: July 2012
  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 4

Study Type: Interventional
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)

Resource links provided by NLM:


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 ]

Enrollment: 274
Study Start Date: July 2006
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Penicillin VK 250 mg b.d.
Drug: Penicillin VK
Biconcave tablet 250mg oral, b.d.
Placebo Comparator: 2
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00552799

Locations
Ireland
South Infirmary-Victoria University Hospital
Cork, Ireland
United Kingdom
Queens Medical Centre
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
Aberdeen Royal Infirmary
Aberdeen, United Kingdom, AB25 2ZN
Amersham Hospital
Amersham, United Kingdom, HP7 0JD
Brighton General Hospital
Brighton, United Kingdom, BN2 3EW
Bristol Royal Infirmary
Bristol, United Kingdom, BS2 8HW
Cumberland Infirmary
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 Hospital
Ipswich, United Kingdom, IP4 5HD
Queen Elizabeth Hospital
King's Lynn, United Kingdom, PE30 4ET
Leicester Royal Infirmary
Leicester, United Kingdom, LE1 5WW
Broadgreen Hospital
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
Hope Hospital
Salford, United Kingdom, M6 8HD
King's Mill Hospital
Sutton in Ashfield, United Kingdom, NG17 4JL
Singleton Hospital
Swansea, United Kingdom, SA2 8QA
Watford General Hospital
Watford, United Kingdom, WD1 8HB
York Hospital
York, United Kingdom, YO31 8HR
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

Additional Information:
No publications provided

Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT00552799     History of Changes
Other Study ID Numbers: 06002, ISRCTN34716921, EudraCT No. 2006-000381-36
Study First Received: November 1, 2007
Last Updated: July 23, 2012
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

Additional relevant MeSH terms:
Cellulitis
Erysipelas
Bacterial Infections
Connective Tissue Diseases
Gram-Positive Bacterial Infections
Infection
Inflammation
Pathologic Processes
Skin Diseases
Skin Diseases, Bacterial
Skin Diseases, Infectious
Streptococcal Infections
Suppuration
Penicillin V
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014