Actively Recruiting
Study With Phage for CF Subjects With Pseudomonas Lung Infection
Led by BiomX Ltd · Updated on 2025-07-22
63
Participants Needed
14
Research Sites
60 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Study With Phage for CF Subjects With Pseudomonas Lung Infection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Cystic fibrosis patients with chronic Pseudomonas aeruginosa lung infection receiving standard inhaled antibiotics or no inhaled antibiotics
- Age 18 years or older
- Lung function (FEV1) between 40% and 80% predicted
- Clinically stable lung disease
- Willing and able to provide sputum samples at study visits by any method
You will not qualify if you...
- Known allergy to bacteriophages or ingredients in the treatment
- Prior bacteriophage therapy within 6 months before screening or Day 1
- Detection of Burkholderia cenocepacia from respiratory tract within 1 year before screening or at screening
- Currently receiving systemic treatment for allergic bronchopulmonary aspergillosis
- Currently treated for active non-tuberculous mycobacteria infection or prior detection of Mycobacterium abscessus within 12 months before screening
- History of severe neutropenia
- History of lung transplant
- History of solid organ transplant
- Acquired or primary immunodeficiency syndrome
- Started or changed CFTR modulator treatment less than 3 months before screening
- Pregnant or breastfeeding female
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Providence Alaska Medical Center
Anchorage, Alaska, United States, 99508
Not Yet Recruiting
3
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Not Yet Recruiting
4
Stanford University
Palo Alto, California, United States, 94061
Not Yet Recruiting
5
University of California San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
6
National Jewish Health
Denver, Colorado, United States, 80206
Actively Recruiting
7
Joe DiMaggio Children's Health
Hollywood, Florida, United States, 33021
Not Yet Recruiting
8
Central Florida Pulmonary Group
Orlando, Florida, United States, 32803
Actively Recruiting
9
Avanza Medical Center
Pensacola, Florida, United States, 32503
Actively Recruiting
10
Rutgers, Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
11
New York Medical College
Hawthorne, New York, United States, 10593
Actively Recruiting
12
Northwell Health
New York, New York, United States, 10028
Actively Recruiting
13
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
14
University of Utah
Salt Lake City, Utah, United States, 84132
Not Yet Recruiting
Research Team
U
Urania Rappo, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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