AchromoPhage for Achromobacter Lung Infection in Cystic Fibrosis
This study is testing a new treatment called AchromoPhage for adults with cystic fibrosis (CF) who have long-term lung infections caused by Achromobacter bacteria. AchromoPhage is a mixture of four natural viruses, called bacteriophages, that are designed to target and kill Achromobacter. The main goal of this study is to see if AchromoPhage is safe and well tolerated. This study plans to enroll 12 participants who are 18 years or older, weigh at least 40 kg, and have stable breathing symptoms. Participants will receive AchromoPhage in different ways: by breathing it in (inhalation), through a vein (intravenous or IV infusion), or both. The study will measure any serious side effects within 42 days.
- Study design
- This is an open-label, randomized pilot and feasibility study involving 12 participants. Participants will be assigned to one of three groups to receive AchromoPhage.
- What's involved
- You will receive the study drug during clinic visits over a period of three weeks. Each participant will receive three weekly administrations with increasing doses.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint for safety is measured at 42 days after treatment.
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Bacteriophages for Adults With Cystic Fibrosis and Chronic Achromobacter Lung Infection
At a glance
Conditions
Where it's being run
2 sites across 2 statesStudy leadership
- Ghady Haidar, MD · PRINCIPAL_INVESTIGATOR · University of Pittsburgh
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Incidence of treatment-related Grade ≥4 adverse events or treatment-limiting toxicities42 Days
Incidence of treatment-related Grade 4 or higher adverse events or any treatment-limiting toxicities, assessed overall and by treatment group, from the first dose through Day 42. Severity grading will follow the protocol-specified adverse event definitions.