New ways to detect lung infections in people with cystic fibrosis
Official title: Study to Enable New Diagnostics for Pulmonary Microbes in People With CF (SEND-CF)
Run by Seattle Children's Hospital · NCT07312734 · Data updated 2026-11-12
This study is testing new methods to find harmful lung bacteria in people with CF who can still produce sputum, especially those on modern CF therapies.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 16 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Seattle Children's Hospital Academic / other |
| Locations | 9 sites (La Jolla, California and 8 other locations) |
| Status | Recruiting |
| Started | March 30, 2026 |
| Main results expected | August 1, 2027 |
| Study ends | August 1, 2027 |
| Registry record updated | July 2, 2026 |
| Trial ID | NCT07312734 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Individuals aged 16 or older with a CF diagnosis who can produce sputum and have FEV1 at least 30% are eligible, excluding those with recent cancer treatment, organ transplant history, or pregnancy.
✕Probably not a fit
Patients whose infections are not detectable by the new methods or who cannot provide sufficient samples may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The SEND-CF study aims to identify alternative sample types and detection methods for lung infections in CF patients, since sputum samples can be harder to obtain with some treatments. Researchers will collect sputum, saliva, blood components, urine, and breath samples from eligible participants to explore improved diagnostic approaches. The study is observational and gathers health information and biospecimens to see if non-sputum samples can reliably reveal infections. Participants will be adults and older adolescents who can produce sputum and meet the other criteria, with samples collected at multiple sites. This work builds on existing CF research and may lead to easier, earlier detection of lung pathogens.
Why it matters
Potential benefit: If successful, patients could benefit from simpler or more accurate infection detection without needing to cough up sputum.
How similar studies have gone: Previous CF infection studies rely on sputum, but this study explores alternative samples; the approach is exploratory and not yet proven.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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The Minnesota Cystic Fibrosis Center
Minneapolis, Minnesota, United States Recruiting -
Washington University School of Medicine
St Louis, Missouri, United States Recruiting -
University of Pennsylvania
Philadelphia, Pennsylvania, United States Recruiting -
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States Recruiting -
University of Texas Southwestern
Dallas, Texas, United States Recruiting -
Froedtert & Medical College of Wisconsin
Milwaukee, Wisconsin, United States Recruiting
Show 3 more locations
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University of California San Diego
La Jolla, California, United States Not yet recruiting -
University of Nebraska Medical Center
Omaha, Nebraska, United States Not yet recruiting -
Nationwide Children's Hospital
Columbus, Ohio, United States Not yet recruiting
Study contacts
- Principal investigator: Gina Hong, MD, MHS — University of Pennsylvania
- Study coordinator: Nikita Midamba
- Email: Nikita.midamba@seattlechildrens.org
- Phone: 206-884-0599
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.