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

NCT04735952 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2023-12-05

No results posted yet for this study

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 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

Sponsors & Collaborators

  • Arizona State University

    collaborator OTHER

  • Children's Hospital Colorado

    collaborator OTHER

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Cystic Fibrosis Foundation

    collaborator OTHER

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Jane E Hill, PhD · University of British Columbia

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-03
Primary Completion
2024-11-30
Completion
2024-12-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04735952 on ClinicalTrials.gov