CYstic Fibrosis bacterioPHage Study at Yale (CYPHY) (NCT04684641) | Clinical Trial Compass
CompletedPhase 1/2
CYstic Fibrosis bacterioPHage Study at Yale (CYPHY)
United States8 participantsStarted 2021-03-29
Plain-language summary
This is a Phase 2 study with primary objective of looking whether YPT-01 phage therapy reduces sputum bacterial load in cystic fibrosis subjects with Pseudomonas aeruginosa.
In addition, study evaluates the safety profile of phage therapy in this patient population.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Capable of giving signed informed consent;
✓. Stated willingness to comply with all study procedures and availability for the duration of the study;
✓. Age ≥18;
✓. CF diagnosis based upon genetics, sweat chloride testing, or clinical manifestations;
✓. Able to provide repeated induced sputum samples;
✓. Able to use a nebulizer;
✓. PsA culture positive on one occasions within past 2 years and in sputum at screening visit;
✓. FEV1 \>40%;
Exclusion criteria
✕. History of solid organ transplant (e.g., lung or liver);
✕. Severe neutropenia, as defined by absolute neutrophil count (ANC) of \< 500 per microliter;
✕. No YPT-01 phage identified that effectively targets sputum PsA;
✕. Treatment for pulmonary exacerbation within the prior 4 weeks;
✕. Change in pulmonary medications within the prior 4 weeks;
✕. Subjects who are pregnant, who intend to become pregnant, or who do not wish to use contraception;