CYstic Fibrosis bacterioPHage Study at Yale (CYPHY)
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|ClinicalTrials.gov Identifier: NCT04684641|
Recruitment Status : Recruiting
First Posted : December 24, 2020
Last Update Posted : April 15, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis||Drug: Standard Dose YPT-01 Other: Placebo||Phase 1 Phase 2|
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 infections. The study has 2 parallel arms of phage therapy and placebo, with all study materials GMP-manufactured. The purpose of this study is to demonstrate efficacy and safety of inhaled (nebulized) phage therapy YPT-01. Clinically stable subjects who have confirmed diagnosis of CF with PsA in sputum cultures on at least two occasions within past year, and in sputum at screening visit, will be recruited into this study.
An open-label extension is available for subjects in the placebo group to receive YPT-01 following completion of blinded portion of the study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||CYstic Fibrosis bacterioPHage Study at Yale (CYPHY): A Single-site, Randomized, Double-blind, Placebo-controlled Study of Bacteriophage Therapy YPT-01 for Pseudomonas Aeruginosa Infections in Adults With Cystic Fibrosis|
|Actual Study Start Date :||March 29, 2021|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||December 2021|
Experimental: Phage therapy
Participants will be randomized to receive 3mL phage therapy, nebulized daily for 7 days.
Drug: Standard Dose YPT-01
Participants will be randomized to receive the standard dose of phage therapy YPT-01.
Other Name: Phage Therapy
Active Comparator: Placebo
Participants will be randomized to receive the 3mL placebo, nebulized daily for 7 days.
Participants will be randomized to receive the placebo.
- Reduction in sputum bacterial culture [ Time Frame: Day 14 ]Reduction in sputum bacterial culture titers of Pseudomonas as measured by colony forming units/mL at day 14
- Change in lung function [ Time Frame: Baseline, day 14, day 21, day 28, and day 56 ]Compare lung function [percent predicted forced expiratory volume in 1 second (FEV1pp)] in subjects randomized to phage therapy and placebo at day 14, 21, 28, and 56
- Change in the rate of pulmonary exacerbations [ Time Frame: Baseline, day 56 ]Compare the rates of pulmonary exacerbations between subjects randomized to phage therapy versus placebo during the first 56 days of the study
- Change in the rate of hospitalization [ Time Frame: Baseline, day 56 ]Compare the rates of hospitalizations between subjects randomized to phage therapy versus placebo during the first 56 days of the study
- Change in the rate of acute antibiotic use [ Time Frame: Baseline, day 56 ]Compare the rates of acute antibiotic use between subjects randomized to phage therapy versus placebo during the first 56 days of the study
- Patient's Quality of Life [ Time Frame: Baseline, day 56 ]Compare the changes in subject-reported quality of life, using the CFQR, between subjects randomized to phage therapy versus placebo during the first 56 days of the study. This survey consists of 50 questions that relate to a subjects clinical condition and mental health. Administration time takes 10 minutes
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04684641
|Contact: Jonathan Koff, MD||+1 (203) email@example.com|
|United States, Connecticut|
|Yale New Haven Hospital||Recruiting|
|New Haven, Connecticut, United States, 06520|
|Contact: Jon Koff, MD 203-737-6963 firstname.lastname@example.org|
|Principal Investigator: Jon Koff, MD|
|Study Director:||Jonathan Koff, MD||Yale University|
|Principal Investigator:||Benjamin Chan, PhD||Yale University|