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

This study has been withdrawn prior to enrollment.
(Study is withdrawn and no one enrolled due to changes in personnel)
Sponsor:
Collaborators:
Tulane University School of Medicine
GlaxoSmithKline
Information provided by:
Ochsner Health System
ClinicalTrials.gov Identifier:
NCT00856089
First received: March 4, 2009
Last updated: May 28, 2013
Last verified: April 2011
  Purpose

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.


Condition Intervention Phase
Methicillin-resistant Staphylococcus Aureus
Drug: Retapamulin
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prevalence of Methicillin-resistant Staphylococcus Aureus (MRSA) in a Medical Center and Efficacy of Altabax in Clearing MRSA Nasal Colonization

Resource links provided by NLM:


Further study details as provided by Ochsner Health System:

Primary Outcome Measures:
  • Eradication of MRSA nasal colonization [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: May 2009
Estimated Study Completion Date: October 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Retapamulin Drug: Retapamulin
Retapamulin ointment, 1%, apply a thin layer, BID for 5 days
Other Name: Altabax

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00856089

Locations
United States, Louisiana
Tulane University School of Medicine
New Orleans, Louisiana, United States, 70112
Ochsner Health System
New Orleans, Louisiana, United States, 70121
Sponsors and Collaborators
Ochsner Health System
Tulane University School of Medicine
GlaxoSmithKline
Investigators
Principal Investigator: Russell W Steele, MD Ochsner Clinic Foundation
  More Information

No publications provided

Responsible Party: Russell W Steele, MD, Ochsner Health System
ClinicalTrials.gov Identifier: NCT00856089     History of Changes
Other Study ID Numbers: ALT112759
Study First Received: March 4, 2009
Last Updated: May 28, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on September 16, 2014