Retapamulin Ointment in Healthy Adults Nasally Colonized With Staphylococcus Aureus
Status:
Completed
Trial end date:
2008-01-01
Target enrollment:
Participant gender:
Summary
This is a Phase I/IIa randomized, double-blind, placebo-controlled study to evaluate the
safety, tolerability, PK, and efficacy of Retapamulin ointment, 1% applied twice daily for 3
or 5 days to the anterior nares of healthy adult subjects who are nasally colonized with S.
aureus. Approximately 57 healthy subjects who are nasal carriers of S. aureus will be
enrolled and stratified in a 2:1 ratio so that at least 38 persistent carriers and 19
intermittent carriers complete the study. Each eligible subject will participate in three
screening visits, a treatment period, and two follow-up visits. Each subject's participation
in the study will be approximately 6 to 10 weeks from screening to the last follow-up visit.
Subjects will participate in up to three screening visits to determine S. aureus culture
positivity and colonization status.