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Improving P. Aeruginosa Detection With Breath-based Diagnostics (IMPACT-Breath) (IMPACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04735952
Recruitment Status : Recruiting
First Posted : February 3, 2021
Last Update Posted : February 5, 2021
Sponsor:
Collaborators:
Arizona State University
Children's Hospital Colorado
National Heart, Lung, and Blood Institute (NHLBI)
Cystic Fibrosis Foundation
Information provided by (Responsible Party):
Jane Hill, PhD, University of British Columbia

Study Description
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Brief Summary:
The study is a breath biomarker validation study. It is anticipated that 300 patients with cystic fibrosis (CF) from 5 clinical sites in the USA will be enrolled. The study is funded by the US NIH and the US Cystic Fibrosis Foundation. Enrollment commenced in May 2019. Sputum, induced sputum, and oropharyngeal swabs will be collected and evaluated at each clinic as part of standard clinical practice. Excess sputum will be sent to Children's Colorado Hospital for molecular analysis. No swabs will be sent anywhere (other than the clinic from which they originate). Breath samples will be taken from all study participants.

Condition or disease
Cystic Fibrosis

Detailed Description:

AIM 1: Refine and validate volatile biomarkers in the breath of adult and pediatric CF patients for detecting established P. aeruginosa lung infections. For each expectorating subject (n ≥ 288; 5 centers), the diagnostic accuracy of the volatile biomarker panel will be tested, with sputum culture as the standard.

AIM 2: Quantify intra-subject breath variability of the target pediatric population. We will collect longitudinal breath samples for two years from P. aeruginosa-negative subjects (n ≥ 58; ~60% non-expectorating) at 4 pediatric CF clinical centers. We will measure intra-subject variance in the breath signatures of expectorating and non-expectorating subjects, with the latter being the target population for the clinical trial. Two to 8 breath samples will be collected per patient.

Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Improving P. Aeruginosa Detection With Breath-based Diagnostics (IMPACT-Breath)
Actual Study Start Date : May 3, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Groups and Cohorts
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Group/Cohort
AIM 1
No-Intervention. Participants in this group will have 1 study visit only. During that visit, breath and sputum samples will be collected.
AIM 2
No-Intervention. Participants in this group will have up to 8 study visits over a 2 year period. During the study visits, breath and sputum samples will be collected.


Outcome Measures
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Primary Outcome Measures :
  1. Differences in concentrations of individual volatile biomarkers and combinations of biomarkers in breath samples obtained from persons with and without P. aeruginosa lung infections [ Time Frame: Enrollment thru 2023. Last Longitudinal Study Visit will be 24 months after last AIM 2 enrollment ]
    Measured using comprehensive two-dimensional gas chromatography of exhaled breath compared to sputum culture (gold standard)


Secondary Outcome Measures :
  1. Intra-subject changes in concentrations of individual volatile biomarkers and combinations of biomarkers in breath samples [ Time Frame: Thru end of 2025 ]
    Breath samples obtained over a duration of two years, measured using comprehensive two-dimensional gas chromatography of exhaled breath


Biospecimen Retention:   Samples With DNA
Breath Samples (The act of analyzing the sample will completely deplete the sample.) Sputum Samples (A portion of the sample may be retained)

Eligibility Criteria
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Ages Eligible for Study:   3 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants will have a diagnosis of cystic fibrosis with cultures that are either P. aeruginosa (Pa) negative or Pa positive.
Criteria

Inclusion Criteria:

  • Aim 1, Cross-Sectional

Inclusion Criteria:

  1. Male or female, ages 8 years and older
  2. Diagnosis of CF based on sweat chloride ≥ 60 mmol/L and/or 2 known CF mutations
  3. Able to expectorate sputum spontaneously or willing to undergo sputum induction procedure
  4. FEV1 ≥ 30% predicted for spontaneous expectorators or FEV1 ≥ 40% predicted for subjects undergoing sputum induction

  5. Either P. aeruginosa (Pa) negative or chronically infected with P. aeruginosa (Pa positive) as defined below:

    a. P. aeruginosa negative: must meet one of the following criteria: i. No growth of Pa in previous 12 months and ≥ 4 consecutive Pa-negative cultures, OR ii. No history of Pa positive airway cultures (sputum, OP, Bronchoalveolar lavage) b. P. aeruginosa positive i. Over 50% of cultures positive and at least 2 cultures positive for Pa in previous 18 months

  6. Willing to participate in and comply with the study procedures and willingness of the subject, parent or legally authorized representative to provide written informed consent.

Exclusion criteria:

  1. Age < 8 years
  2. Intermittently infected with Pa
  3. Unable to expectorate sputum or undergo sputum induction
  4. FEV1 < 30%
  5. History of lung transplant
  6. Presence of a condition or abnormality that in the opinion of the Principal Investigator would compromise the safety of the subject or the quality of the data.

Aim 2, Longitudinal

Inclusion Criteria, Expectorating Cohort (n=48):

  1. Male or female, ages 8-16 years
  2. Diagnosis of CF based on sweat chloride ≥ 60 mmol/L and/or 2 known CF mutations
  3. Able to expectorate sputum spontaneously or willing to undergo sputum induction procedure
  4. FEV1 ≥ 30% predicted for spontaneous expectorators or FEV1 ≥ 40% predicted for subjects undergoing sputum induction

  5. P. aeruginosa negative, based on one of the following criteria:

    1. No growth of Pa in previous 12 months and ≥ 4 consecutive Pa-negative cultures
    2. No history of Pa positive airway cultures (sputum, OP, bronchoalveolar lavage)
  6. Willing to participate in and comply with the study procedures and willingness of the subject, parent or legally authorized representative to provide written informed consent.

Exclusion criteria:

  1. Age < 8 years
  2. Intermittently or chronically infected with Pa
  3. Unable to expectorate sputum or undergo sputum induction
  4. FEV1 < 30%
  5. History of lung transplant
  6. Presence of a condition or abnormality that in the opinion of the Principal Investigator would compromise the safety of the subject or the quality of the data.

Inclusion Criteria, Non-Expectorating Cohort (n=10):

  1. Male or female, ages 3-8 years
  2. Diagnosis of CF based on sweat chloride ≥ 60 mmol/L and/or 2 known CF mutations 3. FEV1 ≥ 30%

4. Unable to expectorate sputum 5. P. aeruginosa negative, based on one of the following criteria:

  1. No growth of Pa in previous 12 months and ≥ 4 consecutive Pa-negative cultures
  2. No history of Pa positive airway cultures (sputum, OP, bronchoalveolar lavage) 6. Willing to participate in and comply with the study procedures and willingness of the subject, parent or legally authorized representative to provide written informed consent.

Exclusion criteria:

  1. Age < 3 years
  2. Intermittently or chronically infected with Pa
  3. FEV1 < 30%
  4. History of lung transplant
  5. Presence of a condition or abnormality that in the opinion of the Principal Investigator would compromise the safety of the subject or the quality of the data.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04735952


Contacts
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Contact: Jane E Hill, PhD 778 879 5105 jane.hill@ubc.ca
Contact: Kathy J Phipps, BA 603-646-3056 kathy.j.phipps@dartmouth.edu

Locations
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United States, Arizona
Phoenix Children's Hospital Recruiting
Phoenix, Arizona, United States, 85016
Contact: Sophia Williams, MD    602-933-0985    swilliams5@phoenixchildrens.com   
Contact: Natalia Argel    602-933-0985    nargel@phoenixchildrens.com   
United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Edith Zemanick, MD    720-777-5426    Edith.Zemanick@childrenscolorado.org   
Contact: Jennifer Sanchez    720-777-4949    jennifer.sanchez@childrenscolorado.org   
National Jewish Health Recruiting
Denver, Colorado, United States, 80206
Contact: Jerry Nick, MD    303-398-1579    NickJ@NJHealth.org   
Contact: Katie Poch    3033981255    pochk@njhealth.org   
United States, New Hampshire
Dartmouth-Hitchcock Medical Center Not yet recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Brian O'Sullivan, MD       Brian.P.O'Sullivan@hitchcock.org   
Contact: Kathy Phipps, BA    8026839291    kathy.j.phipps@dartmouth.edu   
United States, Ohio
Cincinnati Children's Hospital Recruiting
Cincinnati, Ohio, United States, 45229-3039
Contact: Gary McPhail, MD    513-636-6771    Gary.McPhail@cchmc.org   
Contact: Kira Proulx    513-636-8449    Kira.Proulx@cchmc.org   
Sponsors and Collaborators
University of British Columbia
Arizona State University
Children's Hospital Colorado
National Heart, Lung, and Blood Institute (NHLBI)
Cystic Fibrosis Foundation
Investigators
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Principal Investigator: Jane E Hill, PhD University of British Columbia
More Information
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Additional Information:

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Responsible Party: Jane Hill, PhD, Associate Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT04735952    
Other Study ID Numbers: 331178/ H20-00071
Pro00043176 ( Other Identifier: Advarra )
HILL18A0 ( Other Grant/Funding Number: Cystic Fibrosis Foundation )
R56HL139846 ( U.S. NIH Grant/Contract )
First Posted: February 3, 2021    Key Record Dates
Last Update Posted: February 5, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jane Hill, PhD, University of British Columbia:
Breath
IMPACT
Additional relevant MeSH terms:
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Cystic Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
 Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases