Study to Enable New Diagnostics for Pulmonary Microbes in People With CF
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16+
SponsorChris Goss
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥ 16 years of age on day of study visit
Documentation of CF Diagnosis
Able to expectorate sputum
Percent predicted FEV1 ≥ 30%
Disqualifiers
History of solid organ transplantation
History of active malignancy (or treatment for malignancy) in 12 months prior to the study visit
Pregnant
Trial population
Study participants will be recruited at Cystic Fibrosis Foundation's Therapeutics Development Network study sites
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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.
Time frame
Baseline VisitSponsors and contacts
Click on the lead sponsor to view all of their trials.
Chris Goss
Lead sponsor
Seattle Children's Hospital
Sponsor institution
Cystic Fibrosis Foundation
Collaborator
University of Pennsylvania
Collaborator
Source ClinicalTrials.gov