Conditions: Infections, Bacterial
Keywords: Altabax SB-275833 retapamulin nasal colonization PK tolerability safety efficacy
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 57
Healthy volunteers: yes

Brief 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.

Detailed description:

Arms:
arm 1: 200mg BID retapamulin 5 days arm 2: 200mg BID placebo 5 days arm 3: 200mg BID retapamulin 3 days and placebo BID 2 days for a total of 5 days

Interventions: intervention 1: retapamulin intervention 2: Retapamulin intervention 3: Placebo
Intervention descriptions: intervention 1: 200mg BID retapamulin 3 days intervention 2: 200mg BID retapamulin 5 days intervention 3: 200mg BID placebo 5 days

Protocol document: