Tuberculosis Volatile Organic Compounds

NCT01379066 | Completed

• 1 other identifier: TB1
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 2

Brief Summary

The Pulmonary Colonization Test is a non-invasive breath test for markers of lower respiratory tract infection, which may predict the probability of mycobacterial organisms in the lower respiratory tract. It consists of:

• A breath collection apparatus for collection of volatile organic compounds in breath onto a sorbent trap and Tedlar bag, as well as for the collection of a separate sample of room air.
• Analysis of the volatile organic compounds in breath 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 lower respiratory tract colonization and infection.
• Analysis of the volatile organic compounds in sputum culture by short acoustic wave/gas chromatography. This study will test the hypothesis that the investigators can identify the presence of mycobacteria in an individual by sampling the breath of patients with active tuberculosis and by sampling "head space" above culture media of sputum provided. This study will test the hypotheses:
• that the investigators can identify positive cultures for mycobacterium tuberculosis through sampling of the headspace above the cultures prior to standard laboratory culture identification
• that the investigators can identify control of tuberculosis by sampling exhaled breath

Conditions

Pulmonary Tuberculosis

Keywords

Mycobacterium tuberculosis; Pulmonary tuberculosis; Electronic nose; Gas chromatography

Outcome Measures

Primary Outcomes (1)

• Identification of tuberculosis from bacterial plates

  Tuberculosis will be identified form culture plates by the volatile organic compound signature

  6 months

Study Arms (2)

Tuberculosis Patients

Suspected Tuberculosis patients

Control

Healthy volunteers

Eligibility Criteria

• Age: 1 Year - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Tuberculosis patients will be enrolled through the Tuberculosis Specialty Clinic in Oxnard, Ca.

You may qualify if:

• Suspected tuberculosis infection or disease
• Positive tuberculosis skin test
• Positive sputum culture for TB
• X-rays indicated possible tuberculosis infection or disease
• ability to give breath and sputum samples at regular intervals

You may not qualify if:

• Heavy smoker
• History of or active pulmonary disease other than tuberculosis

Sponsors & Collaborators

• Landon Pediatric Foundation: lead

Study Sites (2)

Oxnard Specialty Clinic

Oxnard, California, 93033, United States

Location

Pediatric Diagnostic Center

Ventura, California, 93003, United States

Location

MeSH Terms

Conditions

Tuberculosis, Pulmonary

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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 (2)