Efficacy Study of Altabax to Clear Methicillin-resistant Staphylococcus Aureus (MRSA) Nasal Colonization

Methicillin-resistant Staphylococcus Aureus Clinical Trial

Official title:

Prevalence of Methicillin-resistant Staphylococcus Aureus (MRSA) in a Medical Center and Efficacy of Altabax in Clearing MRSA Nasal Colonization

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00856089
• Other study ID #: ALT112759
• Status: Withdrawn
• Phase: Phase 4
• Start date: May 2009
• Est. completion date: October 2009

Study information

• Verified date: September 2018
• Source: Ochsner Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to determine whether Altabax (retapamulin ointment, 1%) is effective in the treatment of methicillin-resistant Staphylococcus aureus (MRSA) nasal colonization. The hypothesis is that the prevalence of MRSA increases as a function of increasing clinical exposure and that the topical antibiotic Altabax is efficacious in clearing MRSA nasal colonization. The prevalence of MRSA nasal colonization among Tulane University medical students and residents and physicians of Tulane Medical Center and Ochsner Medical Center will be investigated. A total of 300 subjects will be recruited for the study. After giving informed consent, subjects will be swabbed to obtain specimens for culture and asked to complete a short survey to assess risk factors. Swabs will be used to directly inoculate three types of plates: CHROMagar MRSA plates, Spectra MRSA plates, and TSA with sheep blood plates. After appropriate incubation, Staph latex slide tests will be done and then results confirmed with cefoxitin disk susceptibility testing. MRSA positive subjects will be offered a treatment protocol with the topical antibiotic Altabax (retapamulin ointment, 1%) to be applied as a thin layer to the anterior nares twice daily for 5 days. After the 5-day treatment is complete, subjects will be retested for the presence of MRSA at day 7, day 12, day 30, and day 90. For this portion of the study, all cultures will additionally undergo disk susceptibility testing for retapamulin, erythromycin, clindamycin (including D-test), trimethoprim sulfa, and mupirocin (5 mcg and 20 mcg disks). In addition, Etests for retapamulin and mupirocin will be done. Genetic isolates will be characterized by rep-PCR pre-treatment and post-treatment. Data will be analyzed for MRSA prevalence and risk factor associations with MRSA colonization. Of those subjects found to be MRSA positive, data from the follow-up cultures will be used to assess the efficacy of Altabax in clearing MRSA nasal colonization.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects must be either a student, resident, or physician at Tulane University or be a resident or physician at Ochsner Medical Center.

Exclusion Criteria:

• Subjects who are pregnant or who are presently taking antibiotics or require treatment with systemic antibiotics at anytime during the course of the study.

Related Conditions & MeSH terms

• Methicillin-resistant Staphylococcus Aureus
• Staphylococcal Infections

Intervention

Drug:
• Retapamulin
Retapamulin ointment, 1%, apply a thin layer, BID for 5 days

Locations

Country	Name	City	State
United States	Ochsner Health System	New Orleans	Louisiana
United States	Tulane University School of Medicine	New Orleans	Louisiana

Sponsors (3)

Lead Sponsor	Collaborator
Ochsner Health System	GlaxoSmithKline, Tulane University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eradication of MRSA nasal colonization		90 days