Programs and studies

Clinical study

Nebulized Bacteriophage Therapy in Cystic Fibrosis Patients With Chronic Pseudomonas Aeruginosa Pulmonary Infection

StatusCompleted
TypeTrial
CountriesCzechia; Spain; Israel; Netherlands; United States
Conditions studiedChronic Pseudomonas Aeruginosa Infection; Cystic Fibrosis
Study years2022–2024
Entry review2026-10-03

Participation

Check the study record or contact the study team for current recruitment and eligibility.

Study eligibility

Key Inclusion Criteria: * Cystic fibrosis patients with chronic Pseudomonas aeruginosa pulmonary infection receiving standard of care CF medications * Age ≥ 18 years * FEV1 ≥ 40% 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. Key Exclusion Criteria: * Known hypersensitivity to bacteriophages or excipients in the formulation. * Receipt of prior bacteriophage therapy within the 6 months prior to Screening * Recovery of Burkholderia species from respiratory tract within 1 year prior to screening * Currently receiving treatment for allergic bronchopulmonary aspergillosis * Currently receiving treatment for active infection with non-tuberculous mycobacteria * History of severe neutropenia * History of lung transplant * History of solid organ transplant * Acquired or primary immunodeficiency syndrome * Initiation or change in CF modulator therapy less than 3 months prior to screening * Pregnant or breastfeeding female

Study description

This is a Phase 1b/2a study with the primary objective to determine if BX004-A is safe and tolerable. Exploratory objectives include whether BX004-A reduces sputum Pseudomonas aeruginosa (PsA) bacterial load in CF subjects with chronic PsA pulmonary infection.

Study registrations

ClinicalTrials.govNCT05010577
Recorded study locations (28)

Locations listed in the study record; this does not confirm current recruitment or treatment outside the study. A site label may be older than the overall study status.

The University of Alabama at Birmingham

Birmingham, Alabama, United States

Recorded site status: Not separately listed. Study location source ↗

Providence Alaska Medical Center

Anchorage, Alaska, United States

Recorded site status: Not separately listed. Study location source ↗

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Recorded site status: Not separately listed. Study location source ↗

Yale University

New Haven, Connecticut, United States

Recorded site status: Not separately listed. Study location source ↗

Children's National Medical Center

Washington D.C., District of Columbia, United States

Recorded site status: Not separately listed. Study location source ↗

University of Florida

Gainesville, Florida, United States

Recorded site status: Not separately listed. Study location source ↗

Joe DiMaggio Children's Hospital

Hollywood, Florida, United States

Recorded site status: Not separately listed. Study location source ↗

Central Florida Pulmonary Group

Orlando, Florida, United States

Recorded site status: Not separately listed. Study location source ↗

Boston Children's Hospital

Boston, Massachusetts, United States

Recorded site status: Not separately listed. Study location source ↗

New York Medical College

Valhalla, New York, United States

Recorded site status: Not separately listed. Study location source ↗

Cincinnati Children's Hospital

Cincinnati, Ohio, United States

Recorded site status: Not separately listed. Study location source ↗

University Hospitals Rainbow Babies and Children's Hospital

Cleveland, Ohio, United States

Recorded site status: Not separately listed. Study location source ↗

Nationwide Children's Hospital

Columbus, Ohio, United States

Recorded site status: Not separately listed. Study location source ↗

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Recorded site status: Not separately listed. Study location source ↗

Medical University of South Carolina

Charleston, South Carolina, United States

Recorded site status: Not separately listed. Study location source ↗

Baylor College of Medicine, Texas Children Clinic

Houston, Texas, United States

Recorded site status: Not separately listed. Study location source ↗

University of Utah

Salt Lake City, Utah, United States

Recorded site status: Not separately listed. Study location source ↗

Seattle Children's Hospital

Seattle, Washington, United States

Recorded site status: Not separately listed. Study location source ↗

University Hospital in Motol

Prague, Czechia

Recorded site status: Not separately listed. Study location source ↗

Rambam Health Care Campus (RHCC) - Ruth Rappaport Children's Hospital

Haifa, Israel

Recorded site status: Not separately listed. Study location source ↗

Carmel Medical Center

Haifa, Israel

Recorded site status: Not separately listed. Study location source ↗

Hadassah University Medical Center

Jerusalem, Israel

Recorded site status: Not separately listed. Study location source ↗

Schneider Children's Medical Center of Israel

Petach Tikvah, Israel

Recorded site status: Not separately listed. Study location source ↗

The Chaim Sheba Medical Center

Ramat Gan, Israel

Recorded site status: Not separately listed. Study location source ↗

Amsterdam Medical Center

Amsterdam, Netherlands

Recorded site status: Not separately listed. Study location source ↗

University Medical Center Utrecht

Utrecht, Netherlands

Recorded site status: Not separately listed. Study location source ↗

Hospital Clinico Universitario Virgen de la Arrixaca

El Palmar, Murcia, Spain

Recorded site status: Not separately listed. Study location source ↗

Vall d'Hebron Barcelona Hospital Campus

Barcelona, Spain

Recorded site status: Not separately listed. Study location source ↗

Sources and updates

Entry reviewed . This is the date of our source review, not a confirmation of availability today.

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Study ID
nct05010577