Status:
COMPLETED
CYstic Fibrosis bacterioPHage Study at Yale (CYPHY)
Lead Sponsor:
Yale University
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 evalua...
Detailed Description
This is a prospective, randomized, placebo-controlled, double-blinded, single-site study of Yale Phage Therapy (YPT) 01 in cystic fibrosis subjects with chronic Pseudomonas aeruginosa airway infection...
Eligibility Criteria
Inclusion
- 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%;
- Clinically stable lung disease, defined as no decrease in FEV1 \>10% or pulmonary exacerbations in the 4 weeks prior to screening;
- 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;
- 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;
- 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
- 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;
- Subjects who are breastfeeding;
- Participation in another clinical research study concurrently or within the prior 2 months;
- Known allergy to soy, egg, yeast, or meat.
- Any genetic or acquired (including medication-induced) immunocompromised condition, beyond the level of immunocompromise typically associated with CF and its management.
Key Trial Info
Start Date :
March 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 22 2023
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04684641
Start Date
March 29 2021
End Date
June 22 2023
Last Update
November 18 2023
Active Locations (1)
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1
Yale New Haven Hospital
New Haven, Connecticut, United States, 06520