Evaluation of Safety and Efficacy of Phage Therapy for Drug-resistant Bacterial Infections: An Exploratory, Prospective Single-arm Study

This study is an investigator-initiated, single-center, exploratory clinical trial designed to evaluate the safety and efficacy of phage therapy in patients with urinary tract infections caused by drug-resistant bacteria. Eligible patients aged 18 to 65 years will receive the phage cocktail intervention according to a predefined dosage regimen, with a treatment course of 2 to 3 days and a follow-up period of 2 to 4 weeks after treatment. The primary outcome measures include the incidence of adverse events during treatment, the pathogen clearance rate, and the improvement of clinical symptoms (e.g., fever, local inflammation). The purpose of this study is to provide a scientific basis for the subsequent clinical application of this phage cocktail, and to explore a novel therapeutic option for patients with drug-resistant bacterial infections who have shown poor responses to conventional antibiotic therapy. All participants will undergo standardized medical monitoring throughout the trial, and their rights and safety will be fully protected by the Institutional Review Board (IRB) during the entire process.

NCT Number	NCT07382271
Lead Sponsor	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Conditions	Urinary Tract Infections, Urinary Tract Infections Caused by Drug-resistant Bacteria
Enrollment	6 participants
Start Date	2026-02
Primary Completion	2026-06 (estimated)
Study Completion	2026-08 (estimated)
Updated on ClinicalTrials.gov	2026-02-02