Study With Phage for CF Subjects With Pseudomonas Lung Infection

This study is testing a treatment called BX004, which is a type of bacteriophage (a virus that infects bacteria), for adults with cystic fibrosis (CF) who have chronic Pseudomonas aeruginosa (PsA) lung infections. The main goal is to see if 8 weeks of taking BX004 twice a day, in addition to your usual CF care, can reduce the amount of PsA in your sputum (mucus coughed up from the lungs) compared to a placebo (an inactive substance). To join, you must be at least 18 years old, have CF with chronic PsA infection, and have stable lung disease. The study will also look at how BX004 affects lung function, quality of life, and safety.

Study design: This is a randomized, double-blind, placebo-controlled study, meaning participants will be randomly assigned to receive either BX004 or a placebo, and neither you nor your doctors will know which you are receiving. The study plans to enroll 63 participants.
What's involved: Participants will receive the study treatment twice daily for 8 weeks and will need to provide sputum samples.
Compensation: Not stated in the trial record.
Follow-up: Participants will be followed for safety for 6 months after their last dose of the study treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Study With Phage for CF Subjects With Pseudomonas Lung Infection

Recruiting

PHASE2Ages 18+InterventionalTreatment

BiomX Ltd

~63 participants

Updated 2025-07-22 on ClinicalTrials.gov

What's tested:BX004Placebo

At a glance

Recruiting sites

9 of 14 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Change in sputum Pseudomonas aeruginosa (PsA) burden at 8 weeks (EOT)

Measured over 8 weeks

Conditions

Chronic Pseudomonas Aeruginosa Infection

Cystic Fibrosis (CF)

Where it's being run

14 sites across 10 states

Florida3

California2

New York2

Alabama1

Alaska1

Arkansas1

Colorado1

New Jersey1

Study leadership

Urania Rappo, MD · STUDY_DIRECTOR · BiomX, Inc.

Who to contact

Urania Rappo, MD

[email protected]

1-617-256-2625

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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

What this trial measures

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

Trialytics