Status:
RECRUITING
Remote Sputum Collection in Cystic Fibrosis
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
Cystic Fibrosis Foundation
Conditions:
Cystic Fibrosis
Infections
Eligibility:
All Genders
18+ years
Brief Summary
Elexacaftor/Tezacaftor/Ivacaftor or Trikafta improves lung health in people with cystic fibrosis (CF), including decreased cough and mucous production. Diagnosing lung infections has become more chall...
Detailed Description
The clinical standard of care of people with CF is conducting sputum culture for infection surveillance and detection. However, the introduction of Elexacaftor/Tezacaftor/Ivacaftor (ETI) and adoption ...
Eligibility Criteria
Inclusion
- People with a diagnosis of cystic fibrosis (CF) based on CF Foundation (CFF) guidelines. The CFF guidelines consider a diagnosis of CF based on: (1) two known disease-causing CFTR mutations (based on historical genetic testing in clinical documentation or PortCF, the CFF patient registry), OR (2) sweat chloride 60 mmol/L (based on historical sweat chloride testing in clinical documentation or PortCF) and phenotypic findings consistent with cystic fibrosis in more than one organ system, OR (3) CFF accredited center physician diagnosis, based on clinical manifestations in the absence of two CFTR mutations with full gene mapping (based on historical genetic testing in clinical documentation or PortCF).
- Age 18 years old or greater
- People with the ability to comply with study visits and study procedures as judged by the investigator.
Exclusion
- Solid organ transplant recipients, given the presence of immunosuppression.
- Those who are unable to tolerate sputum induction (hypertonic saline) or the inability to attempt sputum expectoration.
- Subjects who do not have access to a FedEx location or pick-up services will be excluded.
Key Trial Info
Start Date :
January 15 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2028
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06950892
Start Date
January 15 2025
End Date
June 30 2028
Last Update
October 1 2025
Active Locations (3)
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1
National Jewish Health
Denver, Colorado, United States, 80206
2
Johns Hopkins University
Baltimore, Maryland, United States, 21287
3
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104