Status:
UNKNOWN
Improving P. Aeruginosa Detection With Breath-based Diagnostics (IMPACT-Breath)
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
Arizona State University
Children's Hospital Colorado
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
3+ years
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...
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 cent...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Aim 1, Cross-Sectional
- IInclusion Criteria:
- 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.
- Exclusion criteria:
- 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
- Inclusion Criteria, Expectorating Cohort (n=48):
- 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.
- Exclusion criteria:
- Age \< 8 years
- Intermittently or chronically infected with Pa
- Unable to expectorate sputum or undergo sputum induction
- 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.
- Inclusion Criteria, Non-Expectorating Cohort (n=10):
- Male or female, ages 3-8 years
- 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:
- 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) 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:
- Age \< 3 years
- Intermittently or chronically 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.
Exclusion
Key Trial Info
Start Date :
May 3 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04735952
Start Date
May 3 2019
End Date
December 31 2024
Last Update
December 5 2023
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
2
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
3
National Jewish Health
Denver, Colorado, United States, 80206
4
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756