Efficacy Study of Altabax to Clear Methicillin-resistant Staphylococcus Aureus (MRSA) Nasal Colonization
Information source: Ochsner Health System
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Methicillin-resistant Staphylococcus Aureus
Intervention: Retapamulin (Drug)
Phase: Phase 4
Status: Withdrawn
Sponsored by: Ochsner Health System Official(s) and/or principal investigator(s):
Russell W Steele, MD, Principal Investigator, Affiliation: Ochsner Clinic Foundation
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.
Clinical Details
Official title: Prevalence of Methicillin-resistant Staphylococcus Aureus (MRSA) in a Medical Center and Efficacy of Altabax in Clearing MRSA Nasal Colonization
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Eradication of MRSA nasal colonization
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Ochsner Health System, New Orleans, Louisiana 70121, United States
Tulane University School of Medicine, New Orleans, Louisiana 70112, United States
Additional Information
Starting date: May 2009
Last updated: May 28, 2013
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