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Phase 2b Randomized, Double-Blind Study with Phage for CF Subjects with Pseudomonas Lung Infection
EU CTIS ID: 2024-519856-94-00
What this study is testing
Efficacy of nebulized BX004 on sputum PsA burden in CF subjects with chronic PsA pulmonary infection at 8 weeks of treatment (end of treatment [EOT])
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Cystic fibrosis patients with chronic Pseudomonas aeruginosa (PsA) pulmonary infection receiving standard of care CF medications
- Age at least 18 years
- FEV1 between 40-80% predicted
- Clinically stable lung disease
- On inhaled antibiotics for Pseudomonas aeruginosa either as a cycling regimen OR continuous regimen (OR no antibiotics)
- Willing and able to provide adequate sputum samples, using any method (spontaneously expectorated or induced, from home or clinic) at study visits
You likely can't join if
- Known hypersensitivity to bacteriophages or excipients in the formulation
- Initiation or change in type of CFTR modulator less than 3 months prior to Screening
- Pregnant or breastfeeding female
- Receipt of prior bacteriophage therapy within 6 months prior to Screening or Day 1
- Detection of Burkholderia cenocepacia within 1 year prior to Screening or Screening culture
- Currently receiving systemic treatment for allergic bronchopulmonary aspergillosis
See the full eligibility criteria
- Cystic fibrosis patients with chronic Pseudomonas aeruginosa (PsA) pulmonary infection receiving standard of care CF medications
- Age at least 18 years
- FEV1 between 40-80% predicted
- Clinically stable lung disease
- On inhaled antibiotics for Pseudomonas aeruginosa either as a cycling regimen OR continuous regimen (OR no antibiotics)
- Willing and able to provide adequate sputum samples, using any method (spontaneously expectorated or induced, from home or clinic) at study visits
- Known hypersensitivity to bacteriophages or excipients in the formulation
- Initiation or change in type of CFTR modulator less than 3 months prior to Screening
- Pregnant or breastfeeding female
- Receipt of prior bacteriophage therapy within 6 months prior to Screening or Day 1
- Detection of Burkholderia cenocepacia within 1 year prior to Screening or 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
- Acquired or primary immunodeficiency syndrome
- History of lung transplant
- History of solid organ transplant
The study team makes the final eligibility decision.
Where it's taking place
- United States
- United Kingdom
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 - 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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.