Bacteriophages for Adults With Cystic Fibrosis and Chronic Achromobacter Lung Infection

Inclusion Criteria

• •In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• •1. Adults of any gender, age 18 years or greater at the time of enrollment.
• •2. Weight of 40 kg or greater.
• •3. Diagnosed with cystic fibrosis (CF).
• •4. Stable respiratory symptoms within 30 days prior to screening.
• •5. Chronic Achromobacter respiratory infection, defined as isolation by culture of Achromobacter species from two or more respiratory, oral, and/or nasopharyngeal samples provided by the participant within 24 months before the date of pre-screening.
• •6. At least one Achromobacter isolate cultured from a respiratory, oral, and/or nasopharyngeal sample provided by the participant no more than 60 days before the date of planned enrollment must be susceptible to at least 1 phage in AchromoPhage cocktail using study assays.
• •7. FEV1 ≥ (greater than or equal to) 40% of predicted at time of screening
• •8. Ability and willingness to provide informed consent or, if applicable, the ability and willingness of legal guardian/representative to provide informed consent.
• •9. Willingness to comply with study procedures.
• •10. Ability to travel to the University of Pittsburgh or the University of California San Diego for phage administration and in-person visits.
• •11. Agreement not to enroll in other bacteriophage studies or receive bacteriophages for clinical care during the study, except in life-saving situations.
• •12. For females of reproductive potential, a negative urine pregnancy test at the time of consent (before randomization and dosing).
• •13. Willingness to use highly effective contraception or other preventive measures to avoid conception during the study and for 6 months after the last phage dose.
• •Note, criteria 5 and 6 are the microbiologic criteria.