Improving P. Aeruginosa Detection With Breath-based Diagnostics (IMPACT-Breath)
IMPACT
4 other identifiers
observational
300
2 countries
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2019
Longer than P75 for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 3, 2019
CompletedFirst Submitted
Initial submission to the registry
January 21, 2021
CompletedFirst Posted
Study publicly available on registry
February 3, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedDecember 5, 2023
December 1, 2023
5.6 years
January 21, 2021
December 2, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
Measured using comprehensive two-dimensional gas chromatography of exhaled breath compared to sputum culture (gold standard)
Enrollment thru 2023. Last Longitudinal Study Visit will be 24 months after last AIM 2 enrollment
Secondary Outcomes (1)
Intra-subject changes in concentrations of individual volatile biomarkers and combinations of biomarkers in breath samples
Thru end of 2025
Study Arms (2)
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.
Eligibility Criteria
Participants will have a diagnosis of cystic fibrosis with cultures that are either P. aeruginosa (Pa) negative or Pa positive.
You may qualify if:
- Aim 1, Cross-Sectional
- Male or female, ages 8 years and older
- Diagnosis of CF based on sweat chloride ≥ 60 mmol/L and/or 2 known CF mutations
- @ BC Children's Hospital only- Non-expectorators are eligible if having a clinically indicated OP swab.
- FEV1 ≥ 30% predicted for spontaneous expectorators or FEV1 ≥ 40% predicted for subjects undergoing sputum induction
- 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
- 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.
You may not qualify if:
- Age \< 8 years
- Intermittently infected with Pa
- FEV1 \< 30%
- History of lung transplant
- 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
- Male or female, ages 8-16 years
- Diagnosis of CF based on sweat chloride ≥ 60 mmol/L and/or 2 known CF mutations
- @ BC Children's Hospital only- Non-expectorators are eligible if having a clinically indicated OP swab.
- FEV1 ≥ 30% predicted for spontaneous expectorators or FEV1 ≥ 40% predicted for subjects undergoing sputum induction
- P. aeruginosa negative, based on one of the following criteria:
- No growth of Pa in previous 12 months and ≥ 4 consecutive Pa-negative cultures
- No history of Pa positive airway cultures (sputum, OP, bronchoalveolar lavage)
- 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.
- Age \< 8 years
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of British Columbialead
- Arizona State Universitycollaborator
- Children's Hospital Coloradocollaborator
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
- Cystic Fibrosis Foundationcollaborator
Study Sites (7)
Phoenix Children's Hospital
Phoenix, Arizona, 85016, United States
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
National Jewish Health
Denver, Colorado, 80206, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229-3039, United States
BC Children's Hospital
Vancouver, British Columbia, V6H3N1, Canada
St. Paul's Hospital
Vancouver, British Columbia, V6Z1Y6, Canada
Related Links
Biospecimen
Breath Samples (The act of analyzing the sample will completely deplete the sample.) Sputum Samples (A portion of the sample may be retained)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jane E Hill, PhD
University of British Columbia
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 21, 2021
First Posted
February 3, 2021
Study Start
May 3, 2019
Primary Completion
November 30, 2024
Study Completion
December 31, 2024
Last Updated
December 5, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share