Safety and Efficacy of Mupirocin in Eradicating Colonization With S. Aureus in Critically Ill Infants
Completed
National Institute of Allergy and Infectious Diseases (NIAID)
Phase 2
2014-04-30
The objective of this trial is 1) to evaluate the safety and clinical acceptability of a
5-day course of mupirocin applied every 8 hours (± 2 hours) to the nares, umbilical and
perianal areas of infants residing in the ICU. 2) to examine the efficacy of mupirocin in
eradicating SA colonization of infants in the ICU, defined as the absence of SA in cultures
of the nares, umbilical, and perianal areas on day 8 (± 2) (primary decolonization) 3) to
examine the efficacy of mupirocin in achieving persistent eradication of SA colonization
among infants residing in the ICU,defined as the absence of SA in cultures of the nares,
umbilical, and perianal areas. Duration is 36 months. Enrolled infants will continue to
receive medical care as they otherwise would if they were not enrolled in the trial. The
study will be powered with a primary endpoint with 126 participants. Enrollment may continue
to 500 participants to power secondary and exploratory endpoints and assist design subsequent
studies.
A Study to Evaluate the Safety and Bioequivalence of Mupirocin Calcium Cream, 2% and Bactroban® Cream and Compare Both to a Vehicle in Treatment of Secondarily Infected Traumatic Skin Lesions.
Completed
Taro Pharmaceuticals USA
Phase 1
2013-02-01
The primary objective of this study is to determine the comparability of the safety and
efficacy of Mupirocin Calcium Cream, 2% and Bactroban® Cream in subjects with secondarily
infected traumatic skin lesions. It will also be determined whether the efficacy of each of
the active treatments is superior to that of the vehicle cream (placebo).
To Compare the Safety and Efficacy of Perrigo's Product to an FDA Approved Product for the Treatment of Secondarily Infected Traumatic Skin Lesions
Completed
Perrigo Company
Phase 3
2019-10-15
To compare the safety and efficacy of Perrigo's product to an FDA approved product, and to
Compare Both Active Treatments to a Vehicle Control in the Treatment of Secondarily Infected
Traumatic Skin Lesions
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