The goal of this Phase 2b clinical trial is to see if nebulized phage (BX004) can treat chronic Pseudomonas aeruginosa (PsA) lung infection in CF subjects. The primary goal is to see if 8 weeks of twice daily BX004 can reduce the amount of PsA in the sputum compared to placebo (on top of background CF therapy).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Key Inclusion Criteria:
* Cystic fibrosis patients with chronic Pseudomonas aeruginosa pulmonary infection receiving standard of care inhaled antibiotics (cycling or continuous regimen) or no inhaled antibiotics
* Age ≥ 18 years
* FEV1 40%-80% 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 or Day 1
* Detection of Burkholderia cenocepacia from respiratory tract within 1 year prior to Screening or from Screening culture
* Currently receiving systemic treatment for allergic bronchopulmonary aspergillosis
* Currently receiving treatment for active infection with non-tuberculous mycobacteria or prior detection of Mycobacterium abscessus in 12 months prior to Screening
* History of severe neutropenia
* History of lung transplant
* History of solid organ transplant
* Acquired or primary immunodeficiency syndrome
* Initiation or change in type of CFTR modulator less than 3 months prior to Screening
* Pregnant or breastfeeding female
Primary outcome measure(s)
Change in sputum Pseudomonas aeruginosa (PsA) burden at 8 weeks (EOT) — 8 weeks Change from baseline in PsA colony-forming units (CFU) per g of sputum
Trial sites (14)
Facility
City
Region
Status
University of Alabama at Birmingham
Birmingham
Alabama
Recruiting
Providence Alaska Medical Center
Anchorage
Alaska
Not Yet Recruiting
University of Arkansas for Medical Sciences
Little Rock
Arkansas
Not Yet Recruiting
Stanford University
Palo Alto
California
Not Yet Recruiting
University of California San Francisco
San Francisco
California
Recruiting
National Jewish Health
Denver
Colorado
Recruiting
Joe DiMaggio Children's Health
Hollywood
Florida
Not Yet Recruiting
Central Florida Pulmonary Group
Orlando
Florida
Recruiting
Avanza Medical Center
Pensacola
Florida
Recruiting
Rutgers, Robert Wood Johnson Medical School
New Brunswick
New Jersey
Recruiting
New York Medical College
Hawthorne
New York
Recruiting
Northwell Health
New York
New York
Recruiting
Vanderbilt University Medical Center
Nashville
Tennessee
Recruiting
University of Utah
Salt Lake City
Utah
Not Yet Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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