Clinical trial: CYstic Fibrosis bacterioPHage Study at Yale (CYPHY) (NCT04684641)

Eligibility criteria:
Inclusion Criteria:

          1. Capable of giving signed informed consent;

          2. Stated willingness to comply with all study procedures and availability for the
             duration of the study;

          3. Age ≥18;

          4. CF diagnosis based upon genetics, sweat chloride testing, or clinical manifestations;

          5. Able to provide repeated induced sputum samples;

          6. Able to use a nebulizer;

          7. PsA culture positive on two occasions within past 2 years and in sputum at screening
             visit;

          8. FEV1 >40% and <100% predicted;

          9. Clinically stable lung disease, defined as no decrease in FEV1 >10% or pulmonary
             exacerbations in the 4 weeks prior to screening;

         10. If on CF modulator therapy (e.g., ivacaftor, ivacaftor/elexacaftor/tezacaftor), then
             subject remains on the same modulator therapy for at least 2 months prior to
             enrollment;

         11. For females of reproductive potential: use of effective contraception for at least 1
             month prior to screening and agreement to use 2 methods of effective contraception
             during study participation and for an additional 6 weeks after the end of YPT-01
             administration;

         12. Males of non-reproductive potential (e.g., documented congenital bilateral absence of
             vas deferens) or males of reproductive potential (e.g., non-vasectomized males or
             males vasectomized less than 120 days prior to study start) that agree to use condoms
             with spermicide while engaging in sexual activity or be sexually abstinent.

        Exclusion Criteria:

          1. History of solid organ transplant (e.g., lung or liver);

          2. Severe neutropenia, as defined by absolute neutrophil count (ANC) of < 500 per
             microliter;

          3. No YPT-01 phage identified that effectively targets sputum PsA;

          4. Prior treatment with phage therapy of any kind;

          5. Treatment for pulmonary exacerbation within the prior 4 weeks;

          6. Change in pulmonary medications within the prior 4 weeks;

          7. Subjects who are pregnant, who intend to become pregnant, or who do not wish to use
             contraception;

          8. Subjects who are breastfeeding;

          9. Participation in another clinical research study concurrently or within the prior 2
             months;

         10. Known allergy to soy, egg, yeast, or meat.

         11. Any genetic or acquired (including medication-induced) immunocompromised condition,
             beyond the level of immunocompromise typically associated with CF and its management.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia.  The patient is sexually active with his wife and does not use any contraception methods.  They have been trying to conceive for the past year with no success.  The patient has a past medical history of recurrent pneumonia, shortness of breath, and  persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol.  The patient has no history of other medical conditions including allergies or any kind of surgery.  On physical examination, the digits show clubbing.  An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test.

Patient description (patient's own words): I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test.

Does the patient match the trial criteria? 1