Treatment Chronic UTI Post Kidney Transplant

Phase 3

Recruiting

• Conditions: Urinary Tract Infections; Transplant-Related Disorder
• Interventions: Biological: Phage

• Registration Number: NCT05967130
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

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 Timeline

• Study Start: 2023-07-01
• Study First Submitted: 2023-07-15
• Study First Submitted QC: 2023-07-21
• Study First Posted: 2023-08-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-29
• Last Update Posted: 2024-05-30
• Primary Completion: 2026-01-01
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

• Rejection periods
• Frail Patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
UC Positives	Phage	Stable Transplanted Patients with Positive UC

Primary Outcome Measures

Name	Time	Method
Urine culture	1 week after administration	Negative Urine Culture

Trial Locations

Locations (1)

Nooshin Dalili; 🇮🇷 Tehran, Iran, Islamic Republic of