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Clinical Trials/ISRCTN34716921
ISRCTN34716921
Completed
Not Applicable

A randomised controlled trial of prophylactic antibiotics for the prevention of recurrent cellulitis (erysipelas) of the leg (PATCH I)

niversity of Nottingham (UK)0 sites260 target enrollmentMay 4, 2006
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ConditionsRecurrent cellulitis of the legSkin and Connective Tissue DiseasesCellulitis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Recurrent cellulitis of the leg
Sponsor
niversity of Nottingham (UK)
Enrollment
260
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 4, 2006
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversity of Nottingham (UK)

Eligibility Criteria

Inclusion Criteria

  • •1\. Aged over 16 years \- no upper age limit, either sex
  • •2\. At least one previous episode of cellulitis of either leg within the three years prior to the current acute index episode of cellulitis.

Exclusion Criteria

  • •Added 09/01/2009:
  • •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:
  • •1\. Taken antibiotic prophylaxis (defined as more than 3 months usage) for the prevention of cellulitis within 6 months prior to index episode
  • •2\. 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
  • •3\. Known allergy to penicillin
  • •4\. 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)
  • •5\. Treating physician or principal investigator unwilling to randomise patient. This includes, but is not limited to:
  • •5\.1\. 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
  • •5\.2\. 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
  • •5\.3\. Concomitant medication that would mean that long\-term penicillin is inappropriate

Outcomes

Primary Outcomes

Not specified

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