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