NCT00552799

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
274

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2006

Longer than P75 for phase_4

Geographic Reach
2 countries

25 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 1, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2007

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

July 24, 2012

Status Verified

July 1, 2012

Enrollment Period

5.3 years

First QC Date

November 1, 2007

Last Update Submit

July 23, 2012

Conditions

Cellulitis/Erysipelas of the Leg

Keywords

cellulitislymphoedemapenicillinclinical trial

Outcome Measures

Primary Outcomes (1)

  • The primary outcome is time to next episode of cellulitis

    variable

Secondary Outcomes (1)

  • 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).

    variable

Study Arms (2)

1

EXPERIMENTAL

Penicillin VK 250 mg b.d.

Drug: Penicillin VK

2

PLACEBO COMPARATOR

placebo tablet b.d.

Other: placebo

Interventions

Penicillin VKDRUG

Biconcave tablet 250mg oral, b.d.

1
placeboOTHER

biconcave tablet matching active comparator as much as possible in size and shape

2

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of cellulitis of either leg AND a history of at least one previous episode of cellulitis of either leg within the three

You may not qualify if:

  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

South Infirmary-Victoria University Hospital

Cork, Ireland

Location

Queens Medical Centre

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

Aberdeen Royal Infirmary

Aberdeen, AB25 2ZN, United Kingdom

Location

Amersham Hospital

Amersham, HP7 0JD, United Kingdom

Location

Brighton General Hospital

Brighton, BN2 3EW, United Kingdom

Location

Bristol Royal Infirmary

Bristol, BS2 8HW, United Kingdom

Location

Cumberland Infirmary

Carlisle, CA2 7HY, United Kingdom

Location

Derbyshire Royal Infirmary

Derby, DE1 2QY, United Kingdom

Location

University Hospital of North Durham

Durham, DE1 5TW, United Kingdom

Location

Gloucestershire Royal Infirmary

Gloucester, GL1 3NN, United Kingdom

Location

James Paget University Hospital

Great Yarmouth, NR31 6LA, United Kingdom

Location

Princess Royal Hospital

Hull, HU8 9HE, United Kingdom

Location

Ipswich Hospital

Ipswich, IP4 5HD, United Kingdom

Location

Queen Elizabeth Hospital

Kings Lynn, PE30 4ET, United Kingdom

Location

Leicester Royal Infirmary

Leicester, LE1 5WW, United Kingdom

Location

Broadgreen Hospital

Liverpool, L14 3LB, United Kingdom

Location

Altnagelvin Area Hospital

Londonderry, BT47 6SB, United Kingdom

Location

Royal Victoria Infirmary

Newcastle upon Tyne, NE1 4LP, United Kingdom

Location

Norfolk and Norwich University Hospital

Norwich, NR4 7UY, United Kingdom

Location

Royal Berkshire Hospital

Reading, RG1 5AN, United Kingdom

Location

Hope Hospital

Salford, M6 8HD, United Kingdom

Location

King's Mill Hospital

Sutton in Ashfield, NG17 4JL, United Kingdom

Location

Singleton Hospital

Swansea, SA2 8QA, United Kingdom

Location

Watford General Hospital

Watford, WD1 8HB, United Kingdom

Location

York Hospital

York, YO31 8HR, United Kingdom

Location

MeSH Terms

Conditions

CellulitisLymphedema

Interventions

Penicillin V

Condition Hierarchy (Ancestors)

Skin Diseases, InfectiousInfectionsSuppurationConnective Tissue DiseasesSkin and Connective Tissue DiseasesInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsLymphatic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Penicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Hywel Williams, Professor

    University of Nottingham

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2007

First Posted

November 2, 2007

Study Start

July 1, 2006

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

July 24, 2012

Record last verified: 2012-07

Locations

IE(1)GB(24)