Chronic Pseudomonas Aeruginosa Infection study: BX004
Official title Study With Phage for CF Subjects With Pseudomonas Lung Infection
ClinicalTrials.gov ID: NCT06998043
What this study is testing
What is BX004?
BX004 is an investigational treatment being studied to see if it can help reduce chronic Pseudomonas aeruginosa lung infections in people with cystic fibrosis. It is designed to use bacteriophages, which are viruses that specifically target and break down bacteria, to lower the amount of Pseudomonas aeruginosa in the lungs.
Also referred to as Nebulized bacteriophages targeting Pseudomonas aeruginosa.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether inhaling BX004 phage twice a day for 8 weeks can reduce Pseudomonas bacteria in the lungs of people with cystic fibrosis.
- Who it's for
- You may be able to join if you have cystic fibrosis and a chronic Pseudomonas lung infection.
- What's involved
- You will breathe in a phage spray or a pretend spray twice a day for 8 weeks, while continuing your usual CF treatments. You will also give sputum samples to measure bacteria.
- Time commitment
- The study lasts 8 weeks, with daily inhalations and regular check‑ins to collect sputum samples.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Cystic fibrosis patients with chronic Pseudomonas aeruginosa pulmonary infection receiving standard of care inhaled antibiotics (cycling or...
- 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...
You likely can't join if
- 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...
- History of severe neutropenia
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- San Francisco, California, United States
- Denver, Colorado, United States
- Orlando, Florida, United States
- Pensacola, Florida, United States
- New Brunswick, New Jersey, United States
- Hawthorne, New York, United States
- New York, New York, United States
- Nashville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; San Francisco, California, United States; Denver, Colorado, United States; Orlando, Florida, United States; Pensacola, Florida, United States; New Brunswick, New Jersey, United States and 3 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.