Efficacy Study of Altabax to Clear Methicillin-Resistant Staphylococcus Aureus (MRSA) Nasal Colonization
Recruitment status was Not yet recruiting
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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 |
|---|---|
|
Methicillin-Resistant Staphylococcus Aureus |
Drug: Retapamulin |
| 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 |
- Eradication of MRSA nasal colonization [ Time Frame: 90 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 300 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | August 2009 |
| Estimated Primary Completion Date: | August 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 |
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| Contact: Jennifer Johnson | 504-919-3312 | jjohnso2@tulane.edu |
| Contact: Lindsay Higgins | 504-975-1383 | lhiggins@tulane.edu |
| United States, Louisiana | |
| Tulane University School of Medicine | Not yet recruiting |
| New Orleans, Louisiana, United States, 70112 | |
| Contact: Jennifer Johnson 504-919-3312 jjohnso2@tulane.edu | |
| Contact: Lindsay Higgins 504-975-1383 lhiggins@tulane.edu | |
| Principal Investigator: Russell W Steele, MD | |
| Sub-Investigator: Jennifer A Johnson, MPH, MS | |
| Sub-Investigator: Lindsay R Higgins | |
| Ochsner Health System | Not yet recruiting |
| New Orleans, Louisiana, United States, 70121 | |
| Contact: Jennifer Johnson 504-919-3312 jjohnso2@tulane.edu | |
| Contact: Lindsay Higgins 504-975-1383 lhiggins@tulane.edu | |
| Principal Investigator: Russell W Steele, MD | |
| Sub-Investigator: Jennifer A Johnson, MPH, MS | |
| Sub-Investigator: Lindsay R Higgins | |
| 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: | March 4, 2009 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Staphylococcal Infections Gram-Positive Bacterial Infections Bacterial Infections Methicillin |
Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013