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

Primary Purpose

Cellulitis/Erysipelas of the Leg

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Penicillin VK
placebo
Sponsored by
University of Nottingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cellulitis/Erysipelas of the Leg focused on measuring cellulitis, lymphoedema, penicillin, clinical trial

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • South Infirmary-Victoria University Hospital
  • Queens Medical Centre
  • Aberdeen Royal Infirmary
  • Amersham Hospital
  • Brighton General Hospital
  • Bristol Royal Infirmary
  • Cumberland Infirmary
  • Derbyshire Royal Infirmary
  • University Hospital of North Durham
  • Gloucestershire Royal Infirmary
  • James Paget University Hospital
  • Princess Royal Hospital
  • Ipswich Hospital
  • Queen Elizabeth Hospital
  • Leicester Royal Infirmary
  • Broadgreen Hospital
  • Altnagelvin Area Hospital
  • Royal Victoria Infirmary
  • Norfolk and Norwich University Hospital
  • Royal Berkshire Hospital
  • Hope Hospital
  • King's Mill Hospital
  • Singleton Hospital
  • Watford General Hospital
  • York Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Penicillin VK 250 mg b.d.

placebo tablet b.d.

Outcomes

Primary Outcome Measures

The primary outcome is time to next episode of cellulitis

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).

Full Information

First Posted
November 1, 2007
Last Updated
July 23, 2012
Sponsor
University of Nottingham
Collaborators
Action Medical Research, UK Dermatology Clinical Trials Network
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1. Study Identification

Unique Protocol Identification Number
NCT00552799
Brief Title
RCT to Investigate if Prophylactic Antibiotics Prevent Further Episodes of Cellulitis (Erysipelas) of the Leg
Acronym
PATCH1
Official Title
Randomised Controlled Trial to Investigate Whether Prophylactic Antibiotics Can Prevent Further Episodes of Cellulitis (Erysipelas) of the Leg (PATCH I)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nottingham
Collaborators
Action Medical Research, UK Dermatology Clinical Trials Network

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cellulitis/Erysipelas of the Leg
Keywords
cellulitis, lymphoedema, penicillin, clinical trial

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
274 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Penicillin VK 250 mg b.d.
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
placebo tablet b.d.
Intervention Type
Drug
Intervention Name(s)
Penicillin VK
Intervention Description
Biconcave tablet 250mg oral, b.d.
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
biconcave tablet matching active comparator as much as possible in size and shape
Primary Outcome Measure Information:
Title
The primary outcome is time to next episode of cellulitis
Time Frame
variable
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hywel Williams, Professor
Organizational Affiliation
University of Nottingham
Official's Role
Study Director
Facility Information:
Facility Name
South Infirmary-Victoria University Hospital
City
Cork
Country
Ireland
Facility Name
Queens Medical Centre
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Aberdeen Royal Infirmary
City
Aberdeen
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Facility Name
Amersham Hospital
City
Amersham
ZIP/Postal Code
HP7 0JD
Country
United Kingdom
Facility Name
Brighton General Hospital
City
Brighton
ZIP/Postal Code
BN2 3EW
Country
United Kingdom
Facility Name
Bristol Royal Infirmary
City
Bristol
ZIP/Postal Code
BS2 8HW
Country
United Kingdom
Facility Name
Cumberland Infirmary
City
Carlisle
ZIP/Postal Code
CA2 7HY
Country
United Kingdom
Facility Name
Derbyshire Royal Infirmary
City
Derby
ZIP/Postal Code
DE1 2QY
Country
United Kingdom
Facility Name
University Hospital of North Durham
City
Durham
ZIP/Postal Code
DE1 5TW
Country
United Kingdom
Facility Name
Gloucestershire Royal Infirmary
City
Gloucester
ZIP/Postal Code
GL1 3NN
Country
United Kingdom
Facility Name
James Paget University Hospital
City
Great Yarmouth
ZIP/Postal Code
NR31 6LA
Country
United Kingdom
Facility Name
Princess Royal Hospital
City
Hull
ZIP/Postal Code
HU8 9HE
Country
United Kingdom
Facility Name
Ipswich Hospital
City
Ipswich
ZIP/Postal Code
IP4 5HD
Country
United Kingdom
Facility Name
Queen Elizabeth Hospital
City
King's Lynn
ZIP/Postal Code
PE30 4ET
Country
United Kingdom
Facility Name
Leicester Royal Infirmary
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Broadgreen Hospital
City
Liverpool
ZIP/Postal Code
L14 3LB
Country
United Kingdom
Facility Name
Altnagelvin Area Hospital
City
Londonderry
ZIP/Postal Code
BT47 6SB
Country
United Kingdom
Facility Name
Royal Victoria Infirmary
City
Newcastle upon Tyne
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
Norfolk and Norwich University Hospital
City
Norwich
ZIP/Postal Code
NR4 7UY
Country
United Kingdom
Facility Name
Royal Berkshire Hospital
City
Reading
ZIP/Postal Code
RG1 5AN
Country
United Kingdom
Facility Name
Hope Hospital
City
Salford
ZIP/Postal Code
M6 8HD
Country
United Kingdom
Facility Name
King's Mill Hospital
City
Sutton in Ashfield
ZIP/Postal Code
NG17 4JL
Country
United Kingdom
Facility Name
Singleton Hospital
City
Swansea
ZIP/Postal Code
SA2 8QA
Country
United Kingdom
Facility Name
Watford General Hospital
City
Watford
ZIP/Postal Code
WD1 8HB
Country
United Kingdom
Facility Name
York Hospital
City
York
ZIP/Postal Code
YO31 8HR
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://www.patchtrial.co.uk
Description
study website

Learn more about this trial

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

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