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

NCT07312734 | Not Yet Recruiting

• 1 other identifier: SENDCF-OB-25
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 9

Brief Summary

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.

Conditions

Cystic Fibrosis (CF); New Diagnostics

Keywords

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

Outcome Measures

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.

  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

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Pennsylvania: collaborator
• Chris Goss: lead
• Cystic Fibrosis Foundation: collaborator

Study Sites (9)

University of California San Diego

La Jolla, California, 92037, United States

Location

The Minnesota Cystic Fibrosis Center

Minneapolis, Minnesota, 55455, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 69198, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15224, United States

Location

University of Texas Southwestern

Dallas, Texas, 75390, United States

Location

Froedtert & Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum, plasma, buffy coat, urine, saliva, sputum, whole blood

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Gina Hong, MD, MHS

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nikita Midamba

CONTACT

206-884-0599; Nikita.midamba@seattlechildrens.org

Anna Mead

CONTACT

206-884-7531; Anna.mead@seattlechildrens.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine and Pediatrics, University of Washington

Study Record Dates

• First Submitted: October 23, 2025
• First Posted: December 31, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: December 31, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)