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Bacteriophages for Adults With Cystic Fibrosis and Chronic Achromobacter Lung Infection

StatusRecruiting
PhasePhase 1
Started
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Record History

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  1. Minor Study sites: 2 to 1 Show 5 more changesShow less
    • Start date changed from estimate of Aug 1, 2026 to Aug 20, 2026
    • Eligibility criteria expanded, about 54 words
    • Secondary endpoints: details revised at 2 of 3 entries
    • Study description shortened, about 16 words
    • Publications: details revised at 8 of 8 entries
  2. Notable Recruitment opened
    • Start date: May 1, 2026 to Aug 1, 2026
    • Site details revised at 2 of 2 sites
    v4
  3. Notable Start date: Mar 2026 to May 1, 2026v3
  4. Notable Start date: Dec 2025 to Mar 2026v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to learn if a new treatment called AchromoPhage is safe and well tolerated in adults with cystic fibrosis (CF) who have long-term lung infections caused by Achromobacter bacteria. AchromoPhage is a mixture of four naturally occurring viruses, called phages, that are designed to target and kill Achromobacter. This study will include 12 participants. People will be randomly assigned to one of three groups to receive AchromoPhage in different ways: by inhalation only, by intravenous (IV) infusion only, or by inhalation followed by IV infusion. Participants will: * Receive the study drug during clinic visits over a period of three weeks. * Provide blood, sputum, nasal, and oral samples so researchers can measure how the phages move through the body, how long they stay, and whether the body develops a response against them. * Complete breathing tests and quality-of-life questionnaires. The main question this study will answer is whether AchromoPhage causes any serious or treatment-limiting side effects in the first 42 days after dosing. Researchers will also look at changes in lung function, quality of life, phage levels in the body, and how the treatment affects Achromobacter and other bacteria in the lungs. The study is being run at the University of Pittsburgh (Pittsburgh, PA).
Trial Details
NCT Number NCT07275905
Lead Sponsor Ghady Haidar
Collaborators: Cystic Fibrosis Foundation
Conditions
(from sponsor)
Cystic Fibrosis (CF), Achromobacter Infection
Related terms Cystic Fibrosis
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov