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.
Age ≥ 18 years.
Confirmed diagnosis of cystic fibrosis.
Sputum culture within 24 months and at screening showing at least one of the following: Pseudomonas aeruginosa, Klebsiella spp., Stenotrophomonas maltophilia, Escherichia coli, Staphylococcus aureus, or Achromobacter xylosoxidans.
Percent predicted FEV₁ ≥ 40% (GLI).
Untreated or uncontrolled mycobacterial or fungal airway infection.
History of Clostridioides difficile without a negative test within 3 months. Concerning exotoxin, virulence, or resistance genes in the bacterial isolate (per investigator).
Mixed-species bacterial infection at screening.
Participation in another interventional trial within 30 days.
Single group
Intravenous Bacteriophage Cocktail plus Standard IV Antibiotics
DrugParticipants 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.
Safety and tolerability of combined IV antibiotic and bacteriophage therapy assessed by the number, type, severity, and relatedness of adverse events (AEs), serious adverse events (SAEs), and events of special interest (ESIs)
Safety will be assessed by the number, type, severity, and relatedness of adverse events (AEs), serious adverse events (SAEs), and events of special interest (ESIs) during and following the 7-day treatment period, in accordance with CTCAE criteria. Monitoring will occur from the initiation of the study drug through the 28-day follow-up period.
Microbiological activity of combined IV antibiotic and bacteriophage therapy
Assessed by changes in bacterial burden in expectorated sputum samples, measured by quantitative culture (CFU/mL) and qPCR for the target pathogen. A response is defined as a ≥0.5 log reduction in bacterial load from baseline.
Microbiological Response: Sputum Bacterial Load (Quantitative Culture) measured by quantitative culture
Change in Sputum Bacterial Load (Quantitative Culture) measured by quantitative culture. Time Frame: Baseline to Day 36 Unit of Measure: CFU/mL
Change in Lung Function (FEV₁ Percent Predicted) measured by percent predicted forced expiratory volume in one second (FEV₁ % predicted).
Change in Lung Function (FEV₁ Percent Predicted) measured by percent predicted forced expiratory volume in one second (FEV₁ % predicted). Unit of Measure: Percent predicted
Change in Respiratory Symptoms Using the Cystic Fibrosis Respiratory Symptom Diary - Chronic Respiratory Infection Symptom Score (Cystic Fibrosis Respiratory Symptom Diary-CRISS)
Change in Respiratory Symptoms Using the Cystic Fibrosis Respiratory Symptom Diary - Chronic Respiratory Infection Symptom Score (Cystic Fibrosis Respiratory Symptom Diary-CRISS). Scores range from 0 (no symptoms) to 100 (most severe symptoms). Unit of Measure: Units on a 0-100 scale
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