Improving P. Aeruginosa Detection With Breath-based Diagnostics (IMPACT-Breath)
NCT ID: NCT04735952
Last Updated: 2023-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2019-05-03
2024-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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AIM 1
No-Intervention. Participants in this group will have 1 study visit only. During that visit, breath and sputum samples will be collected.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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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. @ BC Children's Hospital only- Non-expectorators are eligible if having a clinically indicated OP swab.
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.
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. @ BC Children's Hospital only- Non-expectorators are eligible if having a clinically indicated OP swab.
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.
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
2. Intermittently 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.
Aim 2, Longitudinal
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.
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.
3 Years
ALL
No
Sponsors
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Arizona State University
OTHER
Children's Hospital Colorado
OTHER
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Cystic Fibrosis Foundation
OTHER
University of British Columbia
OTHER
Responsible Party
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Jane Hill, PhD
Associate Professor
Principal Investigators
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Jane E Hill, PhD
Role: PRINCIPAL_INVESTIGATOR
University of British Columbia
Locations
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Phoenix Children's Hospital
Phoenix, Arizona, United States
Children's Hospital Colorado
Aurora, Colorado, United States
National Jewish Health
Denver, Colorado, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, United States
BC Children's Hospital
Vancouver, British Columbia, Canada
St. Paul's Hospital
Vancouver, British Columbia, Canada
Countries
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Central Contacts
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Facility Contacts
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Brian O'Sullivan, MD
Role: primary
Kathy Phipps, BA
Role: backup
Jonathan Rayment, MD
Role: primary
Alam Lakhani
Role: backup
Bradley Quon, MD
Role: primary
Related Links
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Public access to study information and clinical site portal.
Other Identifiers
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Pro00043176
Identifier Type: OTHER
Identifier Source: secondary_id
HILL18A0
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
331178/ H20-00071
Identifier Type: -
Identifier Source: org_study_id