Study With Phage for CF Subjects With Pseudomonas Lung Infection (NCT06998043) | Clinical Trial Compass
RecruitingPhase 2
Study With Phage for CF Subjects With Pseudomonas Lung Infection
United States63 participantsStarted 2025-07-02
Plain-language summary
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).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Inclusion 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 Exclusion Criteria:
* 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 they're measuring
1
Change in sputum Pseudomonas aeruginosa (PsA) burden at 8 weeks (EOT)