Nebulized Bacteriophage Therapy in Cystic Fibrosis Patients With Chronic Pseudomonas Aeruginosa Pulmonary Infection
NCT ID: NCT05010577
Last Updated: 2025-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
43 participants
INTERVENTIONAL
2022-06-21
2024-03-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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BX004-A
Participants will be randomized to receive standard dose of nebulized bacteriophage
BX004-A
Combination of nebulized bacteriophages targeting Pseudomonas aeruginosa
Placebo
Participants will be randomized to receive nebulized placebo
Placebo
Nebulized placebo
Interventions
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BX004-A
Combination of nebulized bacteriophages targeting Pseudomonas aeruginosa
Placebo
Nebulized placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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BiomX, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Urania Rappo, MD
Role: STUDY_DIRECTOR
BiomX, Inc.
Locations
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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
University Medical Center Utrecht
Utrecht, , Netherlands
Hospital Clinico Universitario Virgen de la Arrixaca
El Palmar, Murcia, Spain
Vall d'Hebron Barcelona Hospital Campus
Barcelona, , Spain
Countries
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Other Identifiers
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BMX-04-001
Identifier Type: -
Identifier Source: org_study_id
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