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Study to Enable New Diagnostics for Pulmonary Microbes in People With CF

NCT ID: NCT07312734

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-02-01

Study Completion Date

2027-08-01

Brief Summary

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Sputum culture has been the best approach to detect harmful bacteria in the lungs of people with cystic fibrosis (CF). With the widespread use of new CF therapies (like Trikafta and Alyftrak), it is more difficult for people with CF to produce sputum even though they still have harmful bacteria in their lungs. The SEND-CF study is being done to see if there are other ways to detect harmful bacteria in the lungs.

Detailed Description

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People with cystic fibrosis (CF) often get lung infections that can make their breathing worse and make their lungs weaker over time. Sputum culture is usually analyzed to find these infections. Currently, many people with CF are using CFTR modulators. These medicines help, but they also make it harder for people to cough up sputum. Even though people with CF are making less sputum, lung infections are still a problem. New ways are needed to check for infections without using sputum.

The SEND-CF study wants to gather health information and samples from people with CF in order to find new and better ways to spot harmful bacteria in the lungs. Participants, who typically are able to produce sputum who consent to participate will be asked to provide samples including sputum, saliva, serum, plasma, buffy coat, urine, and whole blood. Some participants will also provide breath samples for a sub-study.

Conditions

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Cystic Fibrosis (CF) New Diagnostics

Keywords

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Cystic Fibrosis CF Breath collection Specimen collection Detection of pathogens New diagnostics

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* ≥ 16 years of age on day of study visit
* Documentation of CF Diagnosis
* Able to expectorate sputum
* Percent predicted FEV1 ≥ 30%

Exclusion Criteria

* History of solid organ transplantation
* History of active malignancy (or treatment for malignancy) in 12 months prior to the study visit
* Pregnant
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chris Goss

OTHER

Sponsor Role lead

Cystic Fibrosis Foundation

OTHER

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role collaborator

Responsible Party

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Chris Goss

Professor of Medicine and Pediatrics, University of Washington

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Gina Hong, MD, MHS

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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University of California San Diego

La Jolla, California, United States

Site Status

The Minnesota Cystic Fibrosis Center

Minneapolis, Minnesota, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status

Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

University of Texas Southwestern

Dallas, Texas, United States

Site Status

Froedtert & Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Central Contacts

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Nikita Midamba

Role: CONTACT

Phone: 206-884-0599

Email: [email protected]

Anna Mead

Role: CONTACT

Phone: 206-884-7531

Email: [email protected]

Facility Contacts

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Jenna Mielke

Role: primary

CF Trials Contact University of Minnesota, Participant Contact

Role: primary

Irma Bauer

Role: primary

Michel Veit

Role: primary

Diana Gilmore

Role: primary

Melissa Molter

Role: primary

Adrienne DeRicco

Role: primary

Ashley Keller

Role: primary

Erin Hubertz

Role: primary

Other Identifiers

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SENDCF-OB-25

Identifier Type: -

Identifier Source: org_study_id