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Safety of Combined Intravenous Antibiotic and Bacteriophage Therapy in Adults With Cystic Fibrosis and Antibiotic-Resistant Lung Infections
Sponsor: University of California, San Diego
Summary
This is a Phase 1, open-label, multi-center pilot study evaluating the safety and microbiological activity of intravenous (IV) bacteriophage therapy in combination with standard IV antibiotics in adults with cystic fibrosis (CF) experiencing pulmonary exacerbations due to antibiotic-resistant bacterial infections. Eligible participants will receive a 7-day course of IV antibiotics, selected by their treating clinician, along with a phage cocktail specifically formulated to target their identified bacterial pathogen (Pseudomonas aeruginosa, Klebsiella spp., Stenotrophomonas maltophilia, Escherichia coli, Staphylococcus aureus, or Achromobacter xylosoxidans). The primary objective is to assess the safety and tolerability of this combined treatment approach. Secondary and exploratory outcomes include assessment of changes in sputum bacterial burden, lung function (spirometry and oscillometry), quality of life, and bacteriophage pharmacokinetics. Results from this study will inform the feasibility and design of future clinical trials using phage therapy in the CF population.
Official title: Taking Advantage of Phage Technologies (TAPT) to Facilitate Phage Therapy While Reducing the Use of Antibiotics in the Management of Cystic Fibrosis (CF)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2025-12-31
Completion Date
2027-01-30
Last Updated
2025-12-12
Healthy Volunteers
No
Conditions
Interventions
Intravenous Bacteriophage Cocktail plus Standard IV Antibiotics
Participants will receive a seven-day course of intravenous (IV) bacteriophage therapy in combination with standard IV antibiotics. The bacteriophage therapy consists of a pathogen-specific cocktail containing four purified, lytic bacteriophages selected based on pre-treatment sensitivity testing of the participant's bacterial isolate. Each phage cocktail targets one of the following antibiotic-resistant pathogens: Pseudomonas aeruginosa, Klebsiella spp., Stenotrophomonas maltophilia, Escherichia coli, Staphylococcus aureus, or Achromobacter xylosoxidans. Phage cocktails are administered IV twice daily at a concentration of 1x10⁹ PFU/mL, following antibiotic infusion. The first three doses are observed in clinic; remaining doses are self-administered at home via PICC line. All phages are produced under GMP conditions and screened to be lytic-only, free of known toxin, resistance, or lysogeny genes.