Volatile Organic Compounds in Staphylococcus Aureus Patients (MRSAVOC)

August 12, 2014 updated by: Chris Landon, Landon Pediatric Foundation

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

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).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Ventura, California, United States, 93003
        • Ventura County Medical Center Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 85 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients will be selected upon suspicion of MRSA or MSSA infection or colonization. Increased concentration will be give to selection of persons from the following high risk groups:

  • It has been documented that the patient has been previously discharged from a general acute care hospital within 30 days prior to the current hospital admission.
  • The patient will be admitted to an intensive care unit or burn unit of the hospital.
  • The patient receives inpatient dialysis treatment.
  • The patient is being transferred from a skilled nursing facility

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Staphylococcus Patients
Patients suspected of having Methicillin-resistant and/or methicillin-susceptible staphylococcus aureus.
Control
Healthy volunteer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of Methicillin Resistant Staphyloccus aureus
Time Frame: one week
Identification during clinic visit of MRSA
one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Landon Pediatric Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

June 21, 2011

First Submitted That Met QC Criteria

June 22, 2011

First Posted (Estimate)

June 23, 2011

Study Record Updates

Last Update Posted (Estimate)

August 13, 2014

Last Update Submitted That Met QC Criteria

August 12, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRSA1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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