Treatment Chronic UTI Post Kidney Transplant

Sponsor

Shahid Beheshti University of Medical Sciences (Other)

Overall Status

Recruiting

CT.gov ID

NCT05967130

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Tract Infections Transplant-Related Disorder	Biological: Phage	Phase 3

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

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: UC Positives Stable Transplanted Patients with Positive UC	Biological: Phage Inserting specific specimen of phages in to the bladder

Arm

Intervention/Treatment

Experimental: UC Positives

Stable Transplanted Patients with Positive UC

Biological: Phage

Inserting specific specimen of phages in to the bladder

Outcome Measures

Primary Outcome Measures

Urine culture [1 week after administration]
Negative Urine Culture

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Rejection periods
Frail Patients

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nooshin Dalili	Tehran		Iran, Islamic Republic of	1666663421

Sponsors and Collaborators

Shahid Beheshti University of Medical Sciences

Investigators

Principal Investigator: Dalili, SBMU

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

nooshin dalili, Assistant Professor, Shahid Beheshti University of Medical Sciences

ClinicalTrials.gov Identifier:

NCT05967130

Other Study ID Numbers:

SBMU-

First Posted:

Aug 1, 2023

Last Update Posted:

Aug 1, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Infections

Urinary Tract Infections

Study Results

No Results Posted as of Aug 1, 2023