Clinical study
Nebulized Bacteriophage Therapy in Cystic Fibrosis Patients With Chronic Pseudomonas Aeruginosa Pulmonary Infection
| Status | Completed |
|---|---|
| Type | Trial |
| Countries | Czechia; Spain; Israel; Netherlands; United States |
| Conditions studied | Chronic Pseudomonas Aeruginosa Infection; Cystic Fibrosis |
| Study years | 2022–2024 |
| Entry review | 2026-10-03 |
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.gov | NCT05010577 |
|---|
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 |
|---|