Infection, Community-AcquiredNCT02981550
Infection Detection by Breath Analysis
An observational study of Infection, Community-Acquired and Communicable Disease, run by BreathTec Biomedical Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Infection, Community-Acquired, Communicable Disease, Respiratory Infection
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Primary care clinic.
Who may be able to join
- 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
Who cannot join
- 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)
About this study
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.
Read the 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.
- Keywords
- Infection
- Medical subject headings
- Community-Acquired Infections, Communicable Diseases, Respiratory Tract Infections, Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of Infection detected by exhaled breath analysis confirmed by laboratory culture
Measured: Within 3 to 7 days of obtaining culture and exhaled breath sample
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study startNov 2016
- Primary completionNov 2017 (estimated)
- Study completionNov 2018 (estimated)
Why it stopped: 2 NaNose devices provided inconsistent results in lab calibration testing
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Infection, Community-AcquiredStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- BreathTec Biomedical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Raj Attariwala, MD PhD, Study director, BreathTec Biomedical Inc.Yazdan Mirzanejad, MD, Principal investigator, Fraser Health/University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02981550
- Sponsor's protocol ID
- Pro18602
- Status last verified
- Nov 2017
- First submitted
- 30 Nov 2016
- Last updated
- 9 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 22327321Thorn 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.
PubMed 22556190Bos 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.
PubMed 23675295
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infection Detection by Breath Analysis
- ClinicalTrials.gov ID
- NCT02981550
- Acronym / sponsor ID
- Pro18602
- Keywords
- Infection
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: 2 NaNose devices provided inconsistent results in lab calibration testing
- Enrolment
- 0 participants (actual)
- Lead sponsor
- BreathTec Biomedical Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2016
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 5 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Primary care clinic.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evidence of Infection detected by exhaled breath analysis confirmed by laboratory culture
Time frame: Within 3 to 7 days of obtaining culture and exhaled breath sample
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2017.
- Background: PubMed 22327321Junger 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.
- Background: PubMed 22556190Thorn 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.
- Background: PubMed 23675295Bos 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raj Attariwala, MD PhD study director
BreathTec Biomedical Inc.
Yazdan Mirzanejad, MD principal investigator
Fraser Health/University of British Columbia
Questions about this trial
What is this clinical trial studying?
An observational study of Infection, Community-Acquired and Communicable Disease, run by BreathTec Biomedical Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of Infection detected by exhaled breath analysis confirmed by laboratory culture (time frame: Within 3 to 7 days of obtaining culture and exhaled breath sample). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02981550, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2017.