NCT05967130

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2023

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2023

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

July 15, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

June 10, 2025

Status Verified

June 1, 2025

Enrollment Period

6 months

First QC Date

July 15, 2023

Last Update Submit

June 5, 2025

Conditions

Urinary Tract InfectionsTransplant-Related Disorder

Outcome Measures

Primary Outcomes (1)

  • Urine culture

    Negative Urine Culture

    1 week after administration

Study Arms (1)

UC Positives

EXPERIMENTAL

Stable Transplanted Patients with Positive UC

Biological: Phage

Interventions

PhageBIOLOGICAL

Inserting specific specimen of phages in to the bladder

UC Positives

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Rejection periods
  • Frail Patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nooshin Dalili

Tehran, 1666663421, Iran

Location

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Dalili

    SBMU

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 15, 2023

First Posted

August 1, 2023

Study Start

July 1, 2023

Primary Completion

January 1, 2024

Study Completion

July 1, 2024

Last Updated

June 10, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

IR(1)