<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02981550</url>
  </required_header>
  <id_info>
    <org_study_id>Pro18602</org_study_id>
    <nct_id>NCT02981550</nct_id>
  </id_info>
  <brief_title>Infection Detection by Breath Analysis</brief_title>
  <official_title>Infection Detection by Breath Analysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>BreathTec Biomedical Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>BreathTec Biomedical Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this feasibility study is to test a device which analyzes breath and may allow&#xD;
      doctors and health professionals to immediately determine if an ill patient has a specific&#xD;
      type of bacterial infection. This will allow a health professional to provide immediate&#xD;
      targeted antibiotics to properly start treatment without delay.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Community acquired, or hospital acquired [nosocomial] infections [pathogens] are a common&#xD;
      cause for morbidity and mortality. Initiation of antibiotic treatment is by best guess or&#xD;
      using a broad spectrum antibiotic. The improper administration of antibiotics is known to&#xD;
      lead to the developing specter of antibiotic resistant organisms.&#xD;
&#xD;
      Certain community acquired bacterial infection such as Streptococcus upper respiratory tract&#xD;
      infections carry increased risk of morbidity secondary to risk of developing abscess,&#xD;
      glomerulonephritis, and/or rheumatic fever. Commonly, most upper respiratory tract infections&#xD;
      are caused by viruses. However due to the unknown pathogen causing an upper respiratory tract&#xD;
      infection, with the risks of potential chronic severe complications from Streptococcus,&#xD;
      initial treatment starts with either an antibiotic, or a typical 3day wait for bacterial&#xD;
      culture result. Quite often, the wait-and-see approach in the community is not undertaken&#xD;
      because of the difficulty in returning for a follow-up appointment.&#xD;
&#xD;
      The risk of a developing antibiotic resistant bacteria is well-known and is one of the&#xD;
      greatest health threats worldwide leading to longer hospitalizations, higher medical costs&#xD;
      and death, according to the World Health Organization. Thus a point of care device which&#xD;
      would enable physicians or other medical practitioners to promptly discriminate between&#xD;
      Streptococcal or other antibiotic sensitive pathogens versus non antibiotic sensitive viral&#xD;
      causes of specific upper respiratory tract infectious pathogens is needed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    2 NaNose devices provided inconsistent results in lab calibration testing&#xD;
  </why_stopped>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">November 2018</completion_date>
  <primary_completion_date type="Anticipated">November 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Evidence of Infection detected by exhaled breath analysis confirmed by laboratory culture</measure>
    <time_frame>Within 3 to 7 days of obtaining culture and exhaled breath sample</time_frame>
  </primary_outcome>
  <enrollment type="Actual">0</enrollment>
  <condition>Infection, Community-Acquired</condition>
  <condition>Communicable Disease</condition>
  <condition>Respiratory Infection</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Exhaled Breath&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Primary care clinic.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Able and willing to participate in this study&#xD;
&#xD;
          -  Availability of signed informed consent&#xD;
&#xD;
          -  Healthy, not on any medication&#xD;
&#xD;
          -  Able to provide a breath sample&#xD;
&#xD;
          -  Having a condition (eg. suspected strep throat, MRSA, C difficile) which would require&#xD;
             a swab/sample for culture&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under the age of 6years&#xD;
&#xD;
          -  Eating food or drink (excluding water) within 2 hours of breath test time&#xD;
&#xD;
          -  Pregnant or Breastfeeding&#xD;
&#xD;
          -  Chronic Obstructive Pulmonary Disease (COPD)&#xD;
&#xD;
          -  Inability to comply with study procedure/unable to follow directions&#xD;
&#xD;
          -  Currently taking antibiotics or other medication (excluding analgesics)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Raj Attariwala, MD PhD</last_name>
    <role>Study Director</role>
    <affiliation>BreathTec Biomedical Inc.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yazdan Mirzanejad, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fraser Health/University of British Columbia</affiliation>
  </overall_official>
  <reference>
    <citation>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.</citation>
    <PMID>22327321</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>22556190</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>23675295</PMID>
  </reference>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>November 7, 2017</last_update_submitted>
  <last_update_submitted_qc>November 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Infection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Respiratory Tract Infections</mesh_term>
    <mesh_term>Community-Acquired Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02981550
org study id: Pro18602
nct id: NCT02981550
lead sponsor: 
has dmc: Yes
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.
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.
observational model: Case-Only
time perspective: Prospective
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
Exhaled Breath
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 6 Years
maximum age: N/A
healthy volunteers: No
last name: Raj Attariwala, MD PhD
role: Study Director
affiliation: BreathTec Biomedical Inc.
last name: Yazdan Mirzanejad, MD
role: Principal Investigator
affiliation: Fraser Health/University of British Columbia
citation: 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
citation: 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
citation: 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
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Respiratory Tract Infections
mesh term: Community-Acquired Infections
sharing ipd: No