Volatile Organic Compounds in Staphylococcus Aureus Patients

NCT01379053 | Completed

• 1 other identifier: MRSA1
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Staphylococcus Aureus; Methicillin-resistant Staphylococcus Aureus; Nosocomial Disease

Keywords

Staphylococcus aureus; Methicillin-resistant staphylococcus aureus; Nosocomial disease; Electronic nose; Gas chromatography

Outcome Measures

Primary Outcomes (1)

• Identification of Methicillin Resistant Staphyloccus aureus

  Identification during clinic visit of MRSA

  one week

Study Arms (2)

Staphylococcus Patients

Patients suspected of having Methicillin-resistant and/or methicillin-susceptible staphylococcus aureus.

Control

Healthy volunteer

Eligibility Criteria

• Age: 1 Year - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Suspicion of staphylococcus aureus infection or colonization
• Able to give samples for zNose® analysis

You may not qualify if:

• Inability to provide sample for zNose® analysis

Sponsors & Collaborators

• Landon Pediatric Foundation: lead

Study Sites (1)

Ventura County Medical Center Hospital

Ventura, California, 93003, United States

Location

MeSH Terms

Conditions

Staphylococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 21, 2011
• First Posted: June 23, 2011
• Study Start: August 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2010
• Last Updated: August 13, 2014

Record last verified: 2014-08

Locations

US (1)