Study to Enable New Diagnostics for Pulmonary Microbes in People With CF
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cystic Fibrosis (CF), New Diagnostics. Basic parameters: from 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Study to Enable New Diagnostics for Pulmonary Microbes in People With CF (SEND-CF)
Overview
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.
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.
Primary outcome 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. [Time frame: Baseline Visit]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 9 centers
- University of California San Diego — La Jolla
- The Minnesota Cystic Fibrosis Center — Minneapolis
- Washington University School of Medicine — St Louis
- University of Nebraska Medical Center — Omaha
- Nationwide Children's Hospital — Columbus
- University of Pennsylvania — Philadelphia
- University of Pittsburgh Medical Center — Pittsburgh
- University of Texas Southwestern — Dallas
- … and 1 more center
Identifiers
NCT: NCT07312734 · SENDCF-OB-25