Back to search results

SEND-CF Study: New Ways to Detect Lung Bacteria in People with CF

The SEND-CF study is looking for new ways to find harmful bacteria in the lungs of people with cystic fibrosis (CF). Traditionally, doctors have used sputum cultures (testing mucus coughed up from the lungs) to find these bacteria. However, new CF medicines like Trikafta and Alyftrak make it harder for people with CF to produce sputum, even though lung infections can still be a problem. This study aims to compare new detection methods against the standard sputum culture. You might be able to join if you are at least 16 years old, have a CF diagnosis, can cough up sputum, and have a certain lung function (FEV1 ≥ 30%).

Study design
This is an observational study planning to enroll 300 participants. It will compare new methods for detecting lung microbes against standard sputum cultures.
What's involved
Participants will provide samples including sputum, saliva, serum, plasma, buffy coat, urine, and whole blood. Some participants will also provide breath samples for a sub-study.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, evaluating detection methods, is measured at the Baseline Visit.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07312734

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

Recruiting
Not specifiedAges 16+Observational
Chris Goss
~300 participants
Updated 2026-07-02 on ClinicalTrials.gov

At a glance

Recruiting sites
6 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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.
Measured over Baseline Visit

Conditions

Cystic Fibrosis (CF)
New Diagnostics

Explore related trials

Cystic Fibrosis

Where it's being run

9 sites across 8 states
Pennsylvania2
California1
Minnesota1
Missouri1
Nebraska1
Ohio1
Texas1
Wisconsin1

Study leadership

  • Gina Hong, MD, MHS · PRINCIPAL_INVESTIGATOR · University of Pennsylvania

Who to contact

Nikita Midamba
[email protected]
206-884-0599
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • 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.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.