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.
1. Aged 18-65 years old. 2. Patients with urinary tract infections caused by drug-resistant bacteria (based on drug susceptibility test results from our hospital or other Grade A tertiary hospitals).
Enterobacteriaceae (e.g., Klebsiella pneumoniae, Escherichia coli): carbapenem or cephalosporin-resistant;
Pseudomonas aeruginosa: carbapenem-resistant;
Enterococci: vancomycin-resistant; ⑤ Staphylococcus aureus: methicillin or vancomycin-resistant; ⑥ Stenotrophomonas maltophilia. Referenced to the WHO Bacterial Priority Pathogens List, 2024
1. Bacterial infection controllable with conventional antibiotic therapy. 2. Presence of undrained urinary tract abscess or obstruction. 3. Severe renal impairment (eGFR <30 mL/min/1.73m²). 4. Concurrent organ failure (heart, liver, lung, etc.). 5. Severe autoimmune diseases. 6. No available phages active against the infecting pathogen. 7. Other conditions deemed unsuitable by the investigator.