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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00903279
Other study ID # TOPS2009
Secondary ID
Status Withdrawn
Phase Phase 2
First received May 14, 2009
Last updated January 30, 2017
Start date August 2009
Est. completion date December 2010

Study information

Verified date May 2009
Source Bay Pines VA Healthcare System
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigators anticipate that utilization of retapamulin preoperatively will eliminate MRSA colonization among patients who are colonized in their nares.


Description:

Enhanced characterization of MRSA strains carried by patients and their eradication prior to surgery will significantly reduce healthcare costs to the VA by reducing the number of MRSA positive patients who need to be isolated and or closely monitored, and allow healthcare providers to better predict the patient's requirements. In addition, the application of molecular methods will facilitate faster tracking of MRSA postoperative infections.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2010
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients who are admitted for an orthopedic surgical procedure

- All patients will be screened and admitted to the study prior to surgery regardless of eventual culture results for MRSA

Exclusion Criteria:

- Pregnancy

- Serious systemic illness due to renal, cardiac or hepatic disease

- Inability to complete follow-up assessments

- Allergy or intolerance to retapamulin

- BMI > 30

- Uncontrolled diabetes, severe anemia, thrombocytopenia or an underlying hematopoietic disorder or malignancy

- Patients with serious life-threatening illnesses and those with terminal illness not expected to survive for two years or more will not be enrolled

- Antibiotics administered during the course of the study will be recorded (name, dose and dates)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Placebo
Placebo will be administered intranasally an amount approximating 0.25 ml will be applied to each nasal vestibule by sterile cotton applicator in the evening prior to surgery and immediately on call on the day of surgery.
Altabax (retapamulin)
Retapamulin 1% ointment will be administered intranasally an amount approximating 0.25 ml will be applied to each nasal vestibule by sterile cotton applicator in the evening prior to surgery and immediately on call on the day of surgery.

Locations

Country Name City State
United States Bay Pines VAHCS Bay Pines Florida

Sponsors (1)

Lead Sponsor Collaborator
Bay Pines VA Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluate efficacy of Retapamulin 1% ointment in eliminating patients MRSA colonization 30 days
Secondary Identify a predominant clone among the MRSA isolates in this study 2 years
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