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

NCT07382271 | Not Yet Recruiting

• 2 other identifiers: SJT2025V2.020250901
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Urinary Tract Infections Caused by Drug-resistant Bacteria; Urinary Tract Infections

Keywords

Phage Therapy; Drug-resistant bacteria; Urinary tract infection; Personalized phage cocktail

Outcome Measures

Primary Outcomes (1)

• Pathogen Clearance Rate

  Baseline (pre-treatment); Days 1, 3, 5, 7 post-treatment

Study Arms (1)

Personalized Phage Cocktail Therapy for Drug-Resistant Urinary Tract Infections

EXPERIMENTAL

This arm enrolls eligible patients with drug-resistant bacterial urinary tract infections (UTIs). The core intervention is personalized phage cocktail therapy, tailored to each patient's isolated drug-resistant pathogen (e.g., carbapenem-resistant Acinetobacter baumannii, Klebsiella pneumoniae, Pseudomonas aeruginosa; vancomycin-resistant Enterococcus; methicillin-resistant Staphylococcus aureus; Stenotrophomonas maltophilia). Key Details of the Intervention: 1\. Phage Cocktail Preparation: Target pathogens isolated from patients' urine samples undergo in vitro lytic phage matching via double-layer agar plate assay or liquid killing curve assay. The cocktail is formulated using lytic phages screened from a high-quality phage library (provided by Chuangshiji (Shanghai) Biotechnology Co., Ltd.), following the group standard T/SHPPA 028-2024 (Quality Requirements for Clinical Therapeutic Bacteriophage Preparations). Each batch is purified and packaged in GMP-compliant facilities, with a s

Biological: Personalized Phage Cocktail

Interventions

Personalized Phage Cocktail BIOLOGICAL

Intravesical perfusion via urinary catheter. 50 mL of diluted phage cocktail (diluted with Ringer's solution if needed) is infused, followed by clamping the catheter for 30 minutes to maximize phage-bacteria contact. Dosing is repeated every 12 hours for 2 or 3 consecutive days (6 total doses).

Personalized Phage Cocktail Therapy for Drug-Resistant Urinary Tract Infections

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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).
• \. The pathogenic bacteria infected by the patient must meet one of the following conditions:
• Pathogenic bacteria are resistant to key antibiotics:
• ① Acinetobacter baumannii: carbapenem-resistant;
• 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
• The pathogenic bacteria are sensitive to key antibiotics in vitro, but treatment with such antibiotics is ineffective or shows insignificant efficacy (the patient's target bacterial infection persists for 7 days or more, and the infection cannot be eradicated despite antibiotic administration during this period).
• The use of key antibiotics to which the pathogenic bacteria are sensitive is restricted (e.g., potential organ toxicity caused by the antibiotics, or the patient is allergic to such antibiotics).
• \. At least one lytic phage targeting the pathogenic bacteria can be screened out.
• \. The patient can tolerate the procedures of intravesical perfusion via urinary catheter, retrograde pyeloperfusion via ureteral catheter, or pyeloperfusion via percutaneous nephrostomy tube, and agrees to receive indwelling or intermittent catheterization during the treatment period.
• \. The subject and their family members (or legal guardian) have fully read and understood the relevant information, and signed the informed consent form.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2026
• First Posted: February 2, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE