Phase 2b Randomized, Double-Blind Study with Phage for CF Subjects with Pseudomonas Lung Infection
Key facts
- Where
- Berlin, Cologne, Essen, Frankfurt Am Main, Jena és Munich, NémetországSee the 6 sites
- Phase
- 2. fázis
Where in Németország
- Charite Universitaetsmedizin Berlin KöRBerlin, NémetországNo longer taking part
- University Hospital Cologne AöRCologne, NémetországNo longer taking part
- Universitaetsklinikum Essen (AoR)Essen, NémetországNo longer taking part
- Goethe University FrankfurtFrankfurt Am Main, NémetországNo longer taking part
- Universitaetsklinikum Jena KöRJena, NémetországNo longer taking part
- LMU Klinikum Muenchen AöRMunich, NémetországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Biomx Ltd.
- Trial code
- EU 2024-519856-94-00
- Record updated
- 2025. október 6.
- Original description
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])Read full original descriptionShow less
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate Nebulized Bacteriophage Treatment in Outpatient Adult Cystic Fibrosis (CF) Subjects with Chronic Pseudomonas aeruginosa (PsA) Pulmonary Infection
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])
Inclusion: 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.
Exclusion: Initiation or change in type of CFTR modulator less than 3 months prior to Screening; 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; Known hypersensitivity to bacteriophages or excipients in the formulation; History of severe neutropenia; Acquired or primary immunodeficiency syndrome; History of lung transplant; History of solid organ transplant; Pregnant or breastfeeding female.