Volatile Organic Compounds in Staphylococcus Aureus Patients

Staphylococcus Aureus Clinical Trial

— MRSAVOC  

Official title:

Detection of Methicillin Resistant Staphylococcus Aureus Colonization Using the zNose®, an Ultra-fast Gas Chromatograph

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01379053
• Other study ID #: MRSA1
• Status: Completed
• Phase: N/A
• First received: June 21, 2011
• Last updated: August 12, 2014
• Start date: August 2009
• Est. completion date: December 2010

Study information

• Verified date: August 2014
• Source: Landon Pediatric Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The zNose® MRSA test is a non-invasive breath test for markers of Staphylococcus aureus, which may predict the probability of bacterial organisms in the anterior nares, throat and respiratory tract, wounds, and anus and therefore be able to replace or supplement current active Methicillin Resistant Staphylococcus Aureus (MRSA) surveillance efforts. It consists of:

• A collection apparatus for collection of volatile compounds from suspected infection sites onto a sorbent trap or Tedlar bag, as well as for the collection of a separate sample of room air.

• Analysis of the volatile organic compounds from suspected infection sites and room air by short acoustic wave gas chromatography.

• Interpretation of the volatile organic compounds with a proprietary algorithm in order to predict the probability of Staphylococcus aureus infection and colonization.

This study will test the hypothesis that we can identify the presence of MRSA by sampling the "head space" above culture media of anterior nare samples provided by patients with MRSA. Additionally, this study will test the hypothesis that we can identify the presence of MRSA by sampling air exhaled through the nostrils (nasal exhalant).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Year to 85 Years

Eligibility

Inclusion Criteria:

• Suspicion of staphylococcus aureus infection or colonization

• Able to give samples for zNose® analysis

Exclusion Criteria:

• Inability to provide sample for zNose® analysis

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Methicillin-resistant Staphylococcus Aureus
• Nosocomial Disease
• Staphylococcal Infections
• Staphylococcus Aureus

Locations

Country	Name	City	State
United States	Ventura County Medical Center Hospital	Ventura	California

Sponsors (1)

Lead Sponsor	Collaborator
Landon Pediatric Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of Methicillin Resistant Staphyloccus aureus	Identification during clinic visit of MRSA	one week	No