Global $17 Million Trial to Evaluate Phage Therapy for Drug-Resistant Recurrent UTIs

As antimicrobial resistance (AMR) continues to limit treatment options for common bacterial infections, an international consortium has launched one of the largest clinical trials to date evaluating bacteriophage therapy as a potential alternative to antibiotics for recurrent urinary tract infections (UTIs).

Supported by a €15 million (approximately $17 million) grant from the European Union, the P-PEAKS UTI trial will bring together 20 research and clinical partners from 13 countries to investigate whether personalized bacteriophage therapy can safely and effectively prevent recurrent Escherichia coli urinary tract infections in women.

Researchers from The Hebrew University of Jerusalem and the Hadassah Medical Organization are among the project's key collaborators, contributing expertise in phage therapy, microbiology, infectious diseases, and translational clinical research.

The trial, known as P-PEAKS UTI (Personalized-Phage against E. coli with IV Antibiotic to Knockout Stable Biofilms in Urinary Tract Infections), is led by Gregory German, MD, of Canada's St. Joseph's Health Centre. The Israeli research team is headed by Ronen Hazan, PhD, Sahar Melamed, PhD, of The Hebrew University, and Ran Nir-Paz, MD, of the Hadassah Medical Organization, who also cofounded the Israeli Phage Therapy Center.

Addressing a Growing Antimicrobial Resistance Challenge

Recurring UTIs affect millions of women worldwide and are becoming increasingly difficult to manage as antibiotic-resistant organisms become more common. Many patients experience repeated infections despite multiple courses of antimicrobial therapy, creating an urgent need for alternative treatment strategies.

Unlike conventional antibiotics, bacteriophages—or phages—are naturally occurring viruses that selectively infect and destroy specific bacteria while leaving human cells unaffected. Because phages target only particular bacterial strains, researchers believe they may offer a more precise approach to treating persistent infections while reducing selective pressure that contributes to antimicrobial resistance.

Approximately 220 women with chronic recurrent Escherichia coli UTIs will be enrolled at clinical sites across Israel, the US, Canada, France, the United Kingdom, Italy, Spain, and Estonia.

Participants will receive either personalized phage therapy or a placebo in combination with a single intravenous dose of antibiotics, allowing investigators to rigorously evaluate the treatment's safety and effectiveness.

Implications for Infection Prevention

For infection prevention and antimicrobial stewardship professionals, the study represents another important step in the search for nontraditional approaches to combating multidrug-resistant infections.

While phage therapy has generated growing scientific interest over the past decade, widespread clinical adoption has been limited by the lack of large, randomized clinical trials. Investigators hope P-PEAKS UTI will provide the high-quality evidence needed to better define the role of phage therapy in routine clinical practice.

"Nonresolving infections and antimicrobial resistance are among the defining medical challenges of our time," said Ran Nir-Paz, MD. "International collaborations such as P-PEAKS allow us to combine expertise across disciplines and countries in order to evaluate innovative therapies that could significantly improve outcomes for patients who currently have few treatment options."

Beyond recurrent UTIs, investigators believe the findings could help establish a stronger scientific foundation for applying bacteriophage therapy to other difficult-to-treat bacterial infections.

As AMR continues to threaten the effectiveness of existing antibiotics, infection preventionists are increasingly recognizing that future solutions will likely require a combination of antimicrobial stewardship, infection prevention practices, rapid diagnostics, novel therapeutics, and international collaboration.

If successful, the P-PEAKS UTI study could represent an important milestone in expanding the evidence base for personalized phage therapy and offering hope to patients who have exhausted conventional treatment options.