Infection Detection by Breath Analysis

NCT02981550 | Withdrawn DMC

• 1 other identifier: Pro18602
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this feasibility study is to test a device which analyzes breath and may allow doctors and health professionals to immediately determine if an ill patient has a specific type of bacterial infection. This will allow a health professional to provide immediate targeted antibiotics to properly start treatment without delay.

Conditions

Infection, Community-Acquired; Communicable Disease; Respiratory Infection

Keywords

Infection

Outcome Measures

Primary Outcomes (1)

• Evidence of Infection detected by exhaled breath analysis confirmed by laboratory culture

  Within 3 to 7 days of obtaining culture and exhaled breath sample

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic.

You may qualify if:

• Able and willing to participate in this study
• Availability of signed informed consent
• Healthy, not on any medication
• Able to provide a breath sample
• Having a condition (eg. suspected strep throat, MRSA, C difficile) which would require a swab/sample for culture

You may not qualify if:

• Under the age of 6years
• Eating food or drink (excluding water) within 2 hours of breath test time
• Pregnant or Breastfeeding
• Chronic Obstructive Pulmonary Disease (COPD)
• Inability to comply with study procedure/unable to follow directions
• Currently taking antibiotics or other medication (excluding analgesics)

Sponsors & Collaborators

• BreathTec Biomedical Inc.: lead

Related Publications (3)

• Junger M, Vautz W, Kuhns M, Hofmann L, Ulbricht S, Baumbach JI, Quintel M, Perl T. Ion mobility spectrometry for microbial volatile organic compounds: a new identification tool for human pathogenic bacteria. Appl Microbiol Biotechnol. 2012 Mar;93(6):2603-14. doi: 10.1007/s00253-012-3924-4. Epub 2012 Feb 12.

  PMID: 22327321 BACKGROUND

• Thorn RM, Greenman J. Microbial volatile compounds in health and disease conditions. J Breath Res. 2012 Jun;6(2):024001. doi: 10.1088/1752-7155/6/2/024001. Epub 2012 May 4.

  PMID: 22556190 BACKGROUND

• Bos LD, Sterk PJ, Schultz MJ. Volatile metabolites of pathogens: a systematic review. PLoS Pathog. 2013 May;9(5):e1003311. doi: 10.1371/journal.ppat.1003311. Epub 2013 May 9.

  PMID: 23675295 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Exhaled Breath

MeSH Terms

Conditions

Community-Acquired Infections; Communicable Diseases; Respiratory Tract Infections; Infections

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Diseases

Study Officials

• Raj Attariwala, MD PhD

  BreathTec Biomedical Inc.

  STUDY DIRECTOR

• Yazdan Mirzanejad, MD

  Fraser Health/University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2016
• First Posted: December 5, 2016
• Study Start: November 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2018
• Last Updated: November 9, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share