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

Description

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.

Conditions

Cystic Fibrosis

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Cystic Fibrosis
Intervention / Treatment

-

Contacts and Locations

Phoenix

Phoenix Children's Hospital, Phoenix, Arizona, United States, 85016

Aurora

Children's Hospital Colorado, Aurora, Colorado, United States, 80045

Denver

National Jewish Health, Denver, Colorado, United States, 80206

Lebanon

Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States, 03756

Cincinnati

Cincinnati Children's Hospital, Cincinnati, Ohio, United States, 45229-3039

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Aim 1, Cross-Sectional
  • 1. Age \< 8 years
  • 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.
  • 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.

Ages Eligible for Study

3 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of British Columbia,

Jane E Hill, PhD, PRINCIPAL_INVESTIGATOR, University of British Columbia

Study Record Dates

2024-12-31