Randomised controlled trials to investigate whether prophylactic antiobiotics can prevent further eisodes of cellulitis (erysipelas) of the leg (PATCH I & PATCH II). - PATCH I & PATCH II

niversity of Nottingham0 sites640 target enrollmentJuly 5, 2006

ConditionsCellulitis of the leg

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cellulitis of the leg
Sponsor: niversity of Nottingham
Enrollment: 640
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 5, 2006

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

niversity of Nottingham

Eligibility Criteria

Inclusion Criteria

•(1\) Diagnosis of cellulitis of eith leg (index episode).
•(2\) History of at least one previous episode od cellulitis of either leg within the three years prior to the index episode.
•(1\) Diagnosis of cellulitis of either leg (index episode).
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range

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:
•(1\) Already taking prophylactic antibiotics for the prevention of cellulitis 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. Prospective participants will be questioned as to the nature of their previous allergic reaction in order to assess whether it was a true allergic response or simply an intolerance to the antibiotic. This questioning will address the following points:
•i) whether the patient experienced a rash;
•ii) when the reaction occurred in relation to administration of the drug;
•iii) which type of penicillin they had.
•Should the clinician deem that the reaction was intolerance rather than an allergic reaction, the clinician will discuss this issue further with the patient. The final decision as to whether to take part in the trial will rest with the patient.
•(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: