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

NCT07382271 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2026-02-02

No results posted yet for this study

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

Interventions

BIOLOGICAL

Personalized Phage Cocktail

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).

Sponsors & Collaborators

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

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2026-06-30
Completion
2026-08-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07382271 on ClinicalTrials.gov