A major international clinical trial backed by a €15 million European Union grant will evaluate whether bacteriophage therapy can offer a safe and effective alternative to antibiotics for treating recurrent urinary tract infections (UTIs) caused by antibiotic-resistant bacteria.
The study, P-PEAKS UTI (Personalized-Phage against E. coli with IV Antibiotic to Knockout Stable Biofilms in Urinary Tract Infections), brings together 20 research and clinical partners across 13 countries. It is led by Dr. Gregory German, a physician at the Chronic Infection Clinic at St. Joseph’s Health Centre, Canada.
Researchers from the Hebrew University of Jerusalem and Hadassah Medical Center are among the key collaborators. The Israeli team is led by Prof. Ronen Hazan and Dr. Sahar Melamed from the Hebrew University, along with Prof. Ran Nir-Paz from Hadassah Medical Center. Prof. Hazan and Prof. Nir-Paz are also the founders and co-leaders of the Israeli Phage Therapy Center (IPTC).
The trial will enroll approximately 220 women suffering from chronic, recurrent Escherichia coli (E. coli) UTIs across clinical sites in Israel, the United States, Canada, France, the United Kingdom, Italy, Spain, and Estonia.
Addressing the Growing Threat of Antibiotic Resistance
Recurrent UTIs affect millions of women worldwide and are becoming increasingly difficult to treat as antibiotic resistance continues to rise. Many patients experience repeated infections despite multiple courses of antibiotics, highlighting the urgent need for new treatment options.
Instead of relying solely on antibiotics, the trial will assess personalized bacteriophage therapy. Bacteriophages, or phages, are naturally occurring viruses that specifically infect and destroy bacteria while leaving human cells unaffected. Because they target only specific bacterial strains, phages may provide a more precise treatment approach while reducing the spread of antimicrobial resistance.
During the study, participants will receive either personalized phage therapy or a placebo alongside a single intravenous dose of antibiotics, allowing researchers to rigorously evaluate the therapy’s safety and effectiveness.
Advancing Phage Therapy Through Global Collaboration
Scientists from Hadassah Medical Center and the Hebrew University will contribute expertise in phage therapy, microbiology, infectious diseases, and translational clinical research. The goal is to generate the high-quality clinical evidence needed to bring phage therapy closer to routine medical use.
“Non-resolving infections and antimicrobial resistance are among the defining medical challenges of our time,” said Profs. Hazan and Nir-Paz. “International collaborations such as P-PEAKS allow us to combine expertise across disciplines and countries to evaluate innovative therapies that could significantly improve outcomes for patients who currently have few treatment options.”
The consortium represents one of the largest international efforts to clinically evaluate phage therapy for recurrent UTIs. Beyond improving treatment for chronic urinary tract infections, researchers hope the project will strengthen the scientific evidence supporting the use of bacteriophages against a broader range of antibiotic-resistant bacterial infections.
If successful, the trial could establish phage therapy as an important new weapon against antimicrobial resistance, offering fresh hope for patients with difficult-to-treat infections while advancing more personalized approaches to infectious disease treatment.
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