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Clinical Trials/NCT05967130
NCT05967130
Terminated
Phase 3

Treatment of Chronic Relapsing Urinary Tract Infection With Bacteriophages in Renal Transplant Patients

Shahid Beheshti University of Medical Sciences1 site in 1 country5 target enrollmentStarted: July 1, 2023Last updated:

Overview

Phase
Phase 3
Status
Terminated
Enrollment
5
Locations
1
Primary Endpoint
Urine culture

Overview

Brief Summary

Urinary tract infections (UTIs) with extended-spectrum -lactamase (ESBL)-positive Enterobacteriums (ESBL-E) are a common infectious complication of renal transplant recipients, with 10% of patients suffering from UTIs with ESBL-E within the first year posttransplant. Moreover, recurrence rates of UTI caused by ESBL-E are almost three times higher than those by cephalosporin-susceptible Enterobacteriums demonstrating the decreased efficacy of antibiotics in the treatment of these UTIs.

Detailed Description

According to each patient's urine culture, resistant urinary tract infections will be treated with specific phages and patients will be followed up with their urine cultures for response to therapy.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Stable Kidney Transplant Recipients
  • Stable Immunosupression Dose
  • Stable Renal Function
  • Resistant Urinary Infection with Positive UC

Exclusion Criteria

  • Rejection periods
  • Frail Patients

Arms & Interventions

UC Positives

Experimental

Stable Transplanted Patients with Positive UC

Intervention: Phage (Biological)

Outcomes

Primary Outcomes

Urine culture

Time Frame: 1 week after administration

Negative Urine Culture

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

nooshin dalili

Assistant Professor

Shahid Beheshti University of Medical Sciences

Study Sites (1)

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