Impetigo Clinical Trial
Official title:
A Randomized, Double-Blind, Double Dummy, Comparative, Multicenter Study to Assess the Safety and Efficacy of Topical Retapamulin Ointment, 1%, Versus Oral Linezolid in the Treatment of Secondarily-Infected Traumatic Lesions and Impetigo Due to Methicillin-Resistant Staphylococcus Aureus
The purpose of this study is to provide further evidence of the clinical and bacteriological efficacy of retapamulin in the treatment of subjects with SITL or impetigo due to MRSA. Subjects aged 2 months and older will be treated with either topical retapamulin for 5 days or oral linezolid for 10 days. The primary endpoint is the clinical response at follow-up (7-9 days after the end of therapy) in subjects who have a MRSA infection at baseline. The primary population is the per-protocol MRSA population. It is anticipated that approximately 500 subjects may be enrolled in order to obtain approximately 105 subjects who have a baseline MRSA infection.
This is a prospective, randomized, double-blind, double dummy, multicenter, comparative
study in subjects 2 months of age and older with SITL (including secondarily-infected
lacerations, sutured wounds and abrasions) or impetigo (bullous and non-bullous) due to
MRSA. A laceration or sutured wound cannot exceed 10 cm in length with surrounding erythema
not extending more than 2 cm from the edge of the lesion. Abrasions cannot exceed 100 cm2 in
total area, or up to a maximum of 2% total body surface area for subjects <18 years of age,
with surrounding erythema not extending more than 2 cm from the edge of the abrasion.
Subjects with impetigo can have up to 10 lesions and the infected lesion(s) must not be more
than 100 cm2 in area (or up to a maximum of 2% total body surface area for subjects <18
years of age), must not require surgical intervention and must be able to be appropriately
treated with a topical antibiotic.
There are five study visits occurring over a 17-19 day period. At the baseline visit (Visit
1, day 1), subjects will be randomized to receive retapamulin (plus oral placebo) or
linezolid (plus placebo ointment) in a 2:1 ratio. Retapamulin is applied twice daily for 5
days, and linezolid is dosed, depending on subject age, either twice or three times daily
for 10 days. The on-therapy, end of therapy and follow-up visits are staggered due to the
difference in duration of the treatment regimens. Subjects will be monitored and clinically
evaluated at all postbaseline visits.
Randomization will be center-based and stratified by age (<5 years, ≥5 to <12 years, ≥12
years), performed using an appropriate Interactive Voice Response System (IVRS), an
automated telephone system. The block size will remain confidential. Subjects are considered
to have completed the study if they meet all inclusion/exclusion criteria, are considered
compliant with study medication, and attend all study visits as defined by the protocol.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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