Nebulized Bacteriophage Therapy in Cystic Fibrosis Patients With Chronic Pseudomonas Aeruginosa Pulmonary Infection
- Conditions
- Chronic Pseudomonas Aeruginosa InfectionCystic Fibrosis
- Interventions
- Drug: Placebo
- Registration Number
- NCT05010577
- Lead Sponsor
- BiomX, Inc.
- Brief Summary
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.
- Detailed Description
This is a randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and tolerability of BX004-A in CF subjects with chronic PsA pulmonary infection. The study is divided into two parts, a single-ascending and multiple-dose phase (Part 1) and a multiple dose phase (Part 2). Subjects in both parts will be included in a 6-month safety follow-up. A Data Safety Monitoring Board will monitor safety in both parts. The purpose of the study is to evaluate safety and tolerability of BX004-A, and whether BX004-A reduces the PsA burden in the sputum of CF subjects with chronic PsA pulmonary infection. Clinically stable CF subjects with a confirmed diagnosis of CF and chronic PsA pulmonary infection will be enrolled.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 32
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants will be randomized to receive nebulized placebo BX004-A BX004-A Participants will be randomized to receive standard dose of nebulized bacteriophage
- Primary Outcome Measures
Name Time Method Safety and tolerability 6 months Incidence of treatment emergent adverse events following single and multiple doses of BX004-A administered by inhalation
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (28)
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States
University Hospitals Rainbow Babies and Children's Hospital
🇺🇸Cleveland, Ohio, United States
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
Baylor College of Medicine, Texas Children Clinic
🇺🇸Houston, Texas, United States
Seattle Children's Hospital
🇺🇸Seattle, Washington, United States
University Hospital in Motol
🇨🇿Prague, Czechia
Providence Alaska Medical Center
🇺🇸Anchorage, Alaska, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Amsterdam Medical Center
🇳🇱Amsterdam, Netherlands
Rambam Health Care Campus (RHCC) - Ruth Rappaport Children's Hospital
🇮🇱Haifa, Israel
Hadassah University Medical Center
🇮🇱Jerusalem, Israel
New York Medical College
🇺🇸Valhalla, New York, United States
The Chaim Sheba Medical Center
🇮🇱Ramat Gan, Israel
Hospital Clinico Universitario Virgen de la Arrixaca
🇪🇸El Palmar, Murcia, Spain
University of Florida
🇺🇸Gainesville, Florida, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Penn State Health Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Carmel Medical Center
🇮🇱Haifa, Israel
Schneider Children's Medical Center of Israel
🇮🇱Petach Tikvah, Israel
Vall d'Hebron Barcelona Hospital Campus
🇪🇸Barcelona, Spain
Joe DiMaggio Children's Hospital
🇺🇸Hollywood, Florida, United States
The University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Central Florida Pulmonary Group
🇺🇸Orlando, Florida, United States
Yale University
🇺🇸New Haven, Connecticut, United States
Cincinnati Children's Hospital
🇺🇸Cincinnati, Ohio, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
University Medical Center Utrecht
🇳🇱Utrecht, Netherlands