Improving P. Aeruginosa Detection With Breath-based Diagnostics (IMPACT-Breath)
Status unconfirmed
Conditions studied: Cystic Fibrosis
In brief
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.
Key facts
- Study ID
- NCT04735952
- Run by
- University of British Columbia
- People needed
- 300
- Starts
- 2019-05-03
- Expected to finish
- 2024-12-31
- Last updated by the study team
- 2023-12-05
Who can join
Age: 3 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
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
- 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%
Where it is running
- BC Children's Hospital — Vancouver, British Columbia, Canada (enrolling)
- St. Paul's Hospital — Vancouver, British Columbia, Canada (enrolling)
- National Jewish Health — Denver, Colorado, United States
- Phoenix Children's Hospital — Phoenix, Arizona, United States
- Cincinnati Children's Hospital — Cincinnati, Ohio, United States
- Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
- Children's Hospital Colorado — Aurora, Colorado, United States
Full record on ClinicalTrials.gov
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