The Efficacy of SinoFresh Nasal and Sinus Care Nasal Spray in Eliminating MRSA From the Nasal Cavity

MRSA Infection Clinical Trial

Official title:

The Efficacy of SinoFresh Nasal and Sinus Care Nasal Spray in Eliminating MRSA From the Nasal Cavity

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00790972
• Other study ID #: 15419A
• Status: Withdrawn
• Phase: N/A
• First received: November 13, 2008
• Last updated: May 19, 2016
• Start date: June 2007
• Est. completion date: June 2013

Study information

• Verified date: May 2016
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This is a study to assess the ability of SinoFresh Nasal & Sinus Care, an FDA approved over-the-counter nasal spray, to eliminate the bacteria in your nose.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2013
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years or older

• The volunteer is able to adhere to the study requirements and study visits.

• Agrees to abstain from use of other nasal sprays for length of study.

• Diagnosis of an MRSA carrier by PCR testing

Exclusion Criteria:

• History of chronic nose bleeds.

• History of intranasal steroids in the last 2 months

• Nasal obstruction severe enough to prohibit effective delivery of a nasal spray

• Epistaxis

• Significant excoriation in the opinion of the Investigator.

• Known hypersensitivity to any ingredients

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• MRSA Infection

Intervention

Drug:
• Sinofresh
two sprays in each nostril three times daily for one week
• Placebo
two sprays in each nostril three times daily for one week

Locations

Country	Name	City	State
United States	The University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	This is a study to assess the ability of SinoFresh Nasal & Sinus Care, an FDA approved over-the-counter nasal spray, to eliminate the bacteria in your nose.		7 days	No