RecruitingPhase 2NCT06998043

Study With Phage for CF Subjects With Pseudomonas Lung Infection

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate Nebulized Bacteriophage Treatment in Outpatient Adult Cystic Fibrosis (CF) Subjects With Chronic Pseudomonas Aeruginosa (PsA) Pulmonary Infection

Sponsor

BiomX Ltd

Enrollment

63 participants

Start Date

Jul 2, 2025

Study Type

INTERVENTIONAL

Conditions

Cystic Fibrosis (CF)Chronic Pseudomonas Aeruginosa Infection

Summary

The goal of this Phase 2b clinical trial is to see if nebulized phage (BX004) can treat chronic Pseudomonas aeruginosa (PsA) lung infection in CF subjects. The primary goal is to see if 8 weeks of twice daily BX004 can reduce the amount of PsA in the sputum compared to placebo (on top of background CF therapy).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called BX004 and Placebo for people with chronic pseudomonas aeruginosa infection and cystic fibrosis (cf). The study is currently recruiting participants at 14 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALBX004

Bacteriophage

OTHERPlacebo

Placebo

Locations(14)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Providence Alaska Medical Center

Anchorage, Alaska, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Stanford University

Palo Alto, California, United States

University of California San Francisco

San Francisco, California, United States

National Jewish Health

Denver, Colorado, United States

Joe DiMaggio Children's Health

Hollywood, Florida, United States

Central Florida Pulmonary Group

Orlando, Florida, United States

Avanza Medical Center

Pensacola, Florida, United States

Rutgers, Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

New York Medical College

Hawthorne, New York, United States

Northwell Health

New York, New York, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

University of Utah

Salt Lake City, Utah, United States

View Full Details on ClinicalTrials.gov

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NCT06998043

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