Nebulized Bacteriophage Therapy in Cystic Fibrosis Patients With Chronic Pseudomonas Aeruginosa Pulmonary Infection
Completed · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Chronic Pseudomonas Aeruginosa Infection, Cystic Fibrosis
In brief
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.
Key facts
- Study ID
- NCT05010577
- Run by
- BiomX, Inc.
- People needed
- 43
- Starts
- 2022-06-21
- Expected to finish
- 2024-03-10
- Last updated by the study team
- 2025-07-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- The 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
- Yale University — New Haven, Connecticut, United States
- Children's National Medical Center — Washington D.C., District of Columbia, United States
- University of Florida — Gainesville, Florida, United States
- Joe DiMaggio Children's Hospital — Hollywood, Florida, United States
- Central Florida Pulmonary Group — Orlando, Florida, United States
- Boston Children's Hospital — Boston, Massachusetts, United States
- New York Medical College — Valhalla, New York, United States
- Cincinnati Children's Hospital — Cincinnati, Ohio, United States
- University Hospitals Rainbow Babies and Children's Hospital — Cleveland, Ohio, United States
- Nationwide Children's Hospital — Columbus, Ohio, United States
- Penn State Health Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
- Medical University of South Carolina — Charleston, South Carolina, United States
- Baylor College of Medicine, Texas Children Clinic — Houston, Texas, United States
- University of Utah — Salt Lake City, Utah, United States
- Seattle Children's Hospital — Seattle, Washington, United States
- University Hospital in Motol — Prague, Czechia
- Rambam Health Care Campus (RHCC) - Ruth Rappaport Children's Hospital — Haifa, Israel
- Carmel Medical Center — Haifa, Israel
- Hadassah University Medical Center — Jerusalem, Israel
- Schneider Children's Medical Center of Israel — Petach Tikvah, Israel
- The Chaim Sheba Medical Center — Ramat Gan, Israel
- Amsterdam Medical Center — Amsterdam, Netherlands
Full record on ClinicalTrials.gov
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