Retapamulin Ointment in Healthy Adults Nasally Colonized With Staphylococcus Aureus

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.

Timeline

Start

2007-09

Primary completion

2008-01

Completion

2008-01

Publications

• Background Naderer OJ, Anderson M, Roberts K, Lou Y, Zhu J, Min S, Scangarella N, Shawar, R. Nasal Decolonization of Persistent Staphylococcus aureus Carriers with Twice Daily Retapamulin Treatment for 3 or 5 Days. Presentation Number L-1492. 48th ICAAC/46th IDSA Annual Meeting, Washington, DC, October 25-28, 2008.
• Background Naderer OJ, Anderson M, Roberts K, Scangarella N, Shawar R, Mundy LM. Case detection of Staphylococcus aureus colonization: screening of the anterior nares (AN) and throat (T). Presentation Number K-3353. 48th Interscience Conference on Antimicrobial Agents and Chemotheraty (ICAAC)/46th Infectious Diseases Society of America (IDSA) Annual Meeting, Washington, DC, October 25-28, 2008.
• Background Scangarella N, Naderer OJ, Anderson M, Roberts K, Sahm D, Shawar R. Antibacterial Activity of Retapamulin and Comparators Against Nasal and Pharyngeal Staphylococcus aureus Isolates Recovered from a Clinical Trial Investigating the Efficacy of Retapamulin in Nasal Decolonization. Presentation Number C1-3840. 48th ICAAC/46th IDSA Annual Meeting, Washington, DC, October 25-28, 2008.

Drugs

Indications