Bacteriophages for Adults With Cystic Fibrosis and Chronic Achromobacter Lung Infection

Laborértékek

• An individual who meets any of the following criteria will be excluded from participation in this study:
  • Serious medical illness requiring systemic treatment or hospitalization within 30 days prior to screening (unless medically stable and approved by the investigator).
  • Acute pulmonary exacerbation requiring systemic antibiotics within 30 days prior to screening.
  • Acute respiratory illness, including viral infection, within 30 days prior to screening.
  • Grade 3 or higher alanine aminotransferase (ALT) or aspartate aminotransferase (AST) at or within 30 days prior to screening, defined as ALT or AST values >5.0 x upper limit of normal (ULN).
  • Currently breastfeeding, pregnant, or planning to become pregnant within 6 months.
  • Hemoglobin < 8 g/dL
  • Absolute neutrophil count < 1000 cells/uL
  • Intolerance to inhaled therapies.
  • Known allergy or sensitivity to components of the AchromoPhage cocktail.
  • Any other condition that, in the investigator's opinion, would interfere with the conduct of the study or would not be in the participant's best interest.

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
  • Adults of any gender, age 18 years or greater at the time of enrollment.
  • Weight of 40 kg or greater.
  • Diagnosed with cystic fibrosis (CF), including transplant recipients
  • Stable respiratory symptoms within 30 days prior to screening, with no change in CF maintenance medications (including cystic fibrosis transmembrane conductance regulator (CFTR) modulators) within 30 days prior to screening.
  • 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. Polymicrobial infection (co-isolation of other organisms) does not exclude participation.
  • At least one Achromobacter isolate cultured from a respiratory, oral, and/or nasopharyngeal sample within 12 months of the date of planned enrollment must be susceptible to at least 1 phage in AchromoPhage cocktail using study assays.
  • FEV1 ≥ (greater than or equal to) 40% of predicted at time of screening
  • Ability and willingness to provide informed consent or, if applicable, the ability and willingness of legal guardian/representative to provide informed consent.
  • Willingness to comply with study procedures.
  • Ability to travel to the University of Pittsburgh or the University of California San Diego if activated for in-person phage administration visits.
  • Agreement not to enroll in other bacteriophage studies or receive bacteriophages for clinical care during the study, except in life-saving situations.
  • For females of reproductive potential, a negative urine pregnancy test at the time of consent (before randomization and dosing).
  • 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.