Study to Enable New Diagnostics for Pulmonary Microbes in People With CF (SEND-CF)

December 16, 2025 updated by: Chris Goss

Study to Enable New Diagnostics for Pulmonary Microbes in People With CF (SEND-CF)

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.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • University of California San Diego
        • Contact:
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • The Minnesota Cystic Fibrosis Center
        • Contact:
          • CF Trials Contact University of Minnesota, Participant Contact
          • Email: cftrials@umn.edu
    • Missouri
      • St Louis, Missouri, United States, 63110
    • Nebraska
      • Omaha, Nebraska, United States, 69198
    • Ohio
    • Pennsylvania
    • Texas
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert & Medical College of Wisconsin
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Study participants will be recruited at Cystic Fibrosis Foundation's Therapeutics Development Network study sites

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate alternative methods for the detection of microbial pathogens from the lungs of people with CF by comparing against the gold standard of sputum cultures.
Time Frame: Baseline Visit
Specimens (including sputum, saliva, blood, urine, and breath (for the Owlstone Device Sub-Study)) will be collected at the Study Visit. These specimens will be stored at a biorepository and be made available to the research community to test and validate diagnostic assays for the detection of CF pathogens.
Baseline Visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chris Goss

Collaborators

University of Pennsylvania
Cystic Fibrosis Foundation

Investigators

  • Principal Investigator: Gina Hong, MD, MHS, University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

October 23, 2025

First Submitted That Met QC Criteria

December 16, 2025

First Posted (Actual)

December 31, 2025

Study Record Updates

Last Update Posted (Actual)

December 31, 2025

Last Update Submitted That Met QC Criteria

December 16, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SENDCF-OB-25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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