RECRUITING

Study With Phage for CF Subjects With Pseudomonas Lung Infection

Description

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).

Conditions

Chronic Pseudomonas Aeruginosa InfectionCystic Fibrosis (CF)
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Related Conditions:

Chronic Pseudomonas Aeruginosa InfectionCystic Fibrosis (CF)

Study Overview

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Study Details

Study overview

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).

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

Study With Phage for CF Subjects With Pseudomonas Lung Infection

Condition
Chronic Pseudomonas Aeruginosa Infection
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham, Birmingham, Alabama, United States, 35233

Anchorage

Providence Alaska Medical Center, Anchorage, Alaska, United States, 99508

Little Rock

University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States, 72205

Palo Alto

Stanford University, Palo Alto, California, United States, 94061

San Francisco

University of California San Francisco, San Francisco, California, United States, 94143

Denver

National Jewish Health, Denver, Colorado, United States, 80206

Hollywood

Joe DiMaggio Children's Health, Hollywood, Florida, United States, 33021

Orlando

Central Florida Pulmonary Group, Orlando, Florida, United States, 32803

Pensacola

Avanza Medical Center, Pensacola, Florida, United States, 32503

New Brunswick

Rutgers, Robert Wood Johnson Medical School, New Brunswick, New Jersey, United States, 08901

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Cystic fibrosis patients with chronic Pseudomonas aeruginosa pulmonary infection receiving standard of care inhaled antibiotics (cycling or continuous regimen) or no inhaled antibiotics
  • * Age ≥ 18 years
  • * FEV1 40%-80% predicted
  • * Clinically stable lung disease
  • * Willing and able to provide adequate sputum samples, using any method (spontaneously expectorated, induced, from home or clinic) at designated study visits.
  • * Known hypersensitivity to bacteriophages or excipients in the formulation.
  • * Receipt of prior bacteriophage therapy within the 6 months prior to Screening or Day 1
  • * Detection of Burkholderia cenocepacia from respiratory tract within 1 year prior to Screening or from Screening culture
  • * Currently receiving systemic treatment for allergic bronchopulmonary aspergillosis
  • * Currently receiving treatment for active infection with non-tuberculous mycobacteria or prior detection of Mycobacterium abscessus in 12 months prior to Screening
  • * History of severe neutropenia
  • * History of lung transplant
  • * History of solid organ transplant
  • * Acquired or primary immunodeficiency syndrome
  • * Initiation or change in type of CFTR modulator less than 3 months prior to Screening
  • * Pregnant or breastfeeding female

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

BiomX Ltd,

Urania Rappo, MD, STUDY_DIRECTOR, BiomX, Inc.

Study Record Dates

2026-09