Infection Detection by Breath Analysis

Withdrawn

• Conditions: Communicable Disease; Infection, Community-Acquired; Respiratory Infection

• Registration Number: NCT02981550
• Lead Sponsor: BreathTec Biomedical Inc.

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.

Detailed Description

Community acquired, or hospital acquired \[nosocomial\] infections \[pathogens\] are a common cause for morbidity and mortality. Initiation of antibiotic treatment is by best guess or using a broad spectrum antibiotic. The improper administration of antibiotics is known to lead to the developing specter of antibiotic resistant organisms.

Certain community acquired bacterial infection such as Streptococcus upper respiratory tract infections carry increased risk of morbidity secondary to risk of developing abscess, glomerulonephritis, and/or rheumatic fever. Commonly, most upper respiratory tract infections are caused by viruses. However due to the unknown pathogen causing an upper respiratory tract infection, with the risks of potential chronic severe complications from Streptococcus, initial treatment starts with either an antibiotic, or a typical 3day wait for bacterial culture result. Quite often, the wait-and-see approach in the community is not undertaken because of the difficulty in returning for a follow-up appointment.

The risk of a developing antibiotic resistant bacteria is well-known and is one of the greatest health threats worldwide leading to longer hospitalizations, higher medical costs and death, according to the World Health Organization. Thus a point of care device which would enable physicians or other medical practitioners to promptly discriminate between Streptococcal or other antibiotic sensitive pathogens versus non antibiotic sensitive viral causes of specific upper respiratory tract infectious pathogens is needed.

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-11-30
• Study First Submitted QC: 2016-11-30
• Study First Posted: 2016-12-05
• Status Verified: 2017-11
• Primary Completion: 2017-11
• Last Update Submitted: 2017-11-07
• Last Update Posted: 2017-11-09
• Study Completion: 2018-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evidence of Infection detected by exhaled breath analysis confirmed by laboratory culture	Within 3 to 7 days of obtaining culture and exhaled breath sample