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NCT Number: NCT07312734

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

Recruiting

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California San Diego, La Jolla, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Mead

CONTACT

[email protected]

206-884-7531

Nikita Midamba

CONTACT

[email protected]

206-884-0599

Sponsors and collaborators

Lead sponsor

Chris Goss

Other

Collaborators

  • Cystic Fibrosis Foundation
  • University of Pennsylvania

Registry information

Official study title

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

Acronym: SEND-CF

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 31, 2025
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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