RECRUITING

Study With Phage for CF Subjects With Pseudomonas Lung Infection

Conditions

Chronic Pseudomonas Aeruginosa Infection Cystic Fibrosis (CF)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2025-07-02

Study Completion:2026-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06998043

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Urania Rappo, MD

CONTACT

1-617-256-2625

uraniar@biomx.com

Principal Investigator

Urania Rappo, MD

STUDY_DIRECTOR

BiomX, Inc.

Study Locations (Sites)

University of Alabama at Birmingham

Birmingham, Alabama, 35233

United States

Providence Alaska Medical Center

Anchorage, Alaska, 99508

United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205

United States

Stanford University

Palo Alto, California, 94061

United States

University of California San Francisco

San Francisco, California, 94143

United States

National Jewish Health

Denver, Colorado, 80206

United States

Joe DiMaggio Children's Health

Hollywood, Florida, 33021

United States

Central Florida Pulmonary Group

Orlando, Florida, 32803

United States

Avanza Medical Center

Pensacola, Florida, 32503

United States

Rutgers, Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901

United States

New York Medical College

Hawthorne, New York, 10593

United States

Northwell Health

New York, New York, 10028

United States

Vanderbilt University Medical Center

Nashville, Tennessee, 37232

United States

University of Utah

Salt Lake City, Utah, 84132

United States

Collaborators and Investigators

Sponsor: BiomX Ltd

Urania Rappo, MD, STUDY_DIRECTOR, BiomX, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-02

Study Completion Date2026-09

Study Record Updates

Study Start Date2025-07-02

Study Completion Date2026-09

Terms related to this study

Additional Relevant MeSH Terms

Chronic Pseudomonas Aeruginosa Infection
Cystic Fibrosis (CF)