Taking Advantage of Phage Technologies (TAPT) to Facilitate Phage Therapy While Reducing the Use of Antibiotics in the Management of Cystic Fibrosis (CF)

Launched by UNIVERSITY OF CALIFORNIA, SAN DIEGO · Jun 24, 2025

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ClinConnect Summary

This clinical trial is exploring a new way to treat lung infections in adults with cystic fibrosis (CF) who have infections that are hard to treat with antibiotics. The study is testing whether adding a special kind of treatment called bacteriophage therapy—using viruses that specifically attack bacteria—along with standard antibiotics is safe and helpful. Participants will receive a 7-day course of intravenous (IV) antibiotics chosen by their doctor, plus a tailored mix of these “phage” viruses designed to target the specific bacteria causing their infection. The main goal is to see if this combined treatment is safe and well-tolerated. Researchers will also look at whether the treatment reduces bacteria in the lungs, improves lung function, and affects quality of life.

To join this study, adults with CF who have moderately severe lung disease and a confirmed bacterial lung infection resistant to some antibiotics may be eligible. Participants need to have a lung function within a certain range and be stable enough to receive IV treatment. People who are pregnant, have untreated other lung infections, or certain allergies won’t be able to join. If accepted, participants can expect careful monitoring during their treatment, including lung tests and tracking how the phage therapy works in their body. This early-phase study will help scientists understand if this new approach is safe and could lead to better treatments for CF lung infections in the future.

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Eligibility criteria

• Subject Inclusion Criteria:
• • 1. Diagnosis of CF confirmed by CFTR genetics analysis or elevated sweat chloride
• • 2. Age\> 18yo at screening
• • 3. Percent predicted FEV1 between 20 and 40% (GLI reference equations between 20 and 40%, or \>40% in those who experience frequent pulmonary exacerbations or have severe disease indicators).
• • 4. SpO2 of \> 88% on pulse oximetry at rest after breathing room air for 20 minutes
• • 5. Previous demonstrated ability to successfully complete home iv therapy with the selected antibiotic in the past 5 years. Waiver of this criteria is possible at the discretion of the investigators and made in conjunction with the primary caring physician.
• • 6. Previous participation in a phage therapy trial is allowed if the inclusion and exclusion criteria are met and at the discretion of the investigators.
• 7. Availability of a phage cocktail that meet the following criteria:
• • 1. Demonstrate lytic activity against the subject's major bacterial pathogen
• • 2. Can be prepared according to FDA specifications at a titer of 1.0 x 10\^9 pfu/dose for 14 doses.
• • Subject Exclusion Criteria
• • 1. Untreated mycobacterial or fungal airway infection defined by professional guidelines
• • a. Note: currently treated mycobacterial disease, airway fungal infection, or fungal prophylaxis therapy may be allowed at the discretion of the clinical investigators.
• • 2. History of active C. difficile colitis infection. Patients with a history of C. difficile colitis must have had one negative stool test within 3 months of screening.
• • 3. Presence of concerning exotoxin, virulence factors or antibiotic resistance genes in the pretreatment sequences of the major isolate or sputum metagenome at the discretion of the investigators.
• • 4. Participants who are pregnant, planning to become pregnant during the study period, or breastfeeding.
• • 5. Known allergy to any of treating materials
• • 6. Any significant historical, clinical, laboratory, information that, in the opinion of the investigator, would make it unsafe for the subject to participate in this study
• • 7. Participation in an interventional/therapeutic trial within 30 days of screening.