Treatment Chronic UTI Post Kidney Transplant | NCT05967130

Studies
Treatment Chronic UTI Post Kidney Transplant

NCT05967130

Sponsor

Shahid Beheshti University of Medical Sciences

Status

Terminated

Last Update Posted

Jun 10, 2025Actual

Enrollment

5Actual

Phase

Phase 3

Conditions

Urinary Tract Infections
Transplant-Related Disorder

Interventions

Phage

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

drug not provided

Expanded Access Info

Start Date

Jul 1, 2023Actual

Primary Completion Date

Jan 1, 2024Actual

Completion Date

Jul 1, 2024Actual

First Submitted Date

Jul 15, 2023

First Submission Date that Met QC Criteria

Jul 21, 2023

First Posted Date

Aug 1, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 5, 2025

Last Update Posted Date

Jun 10, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

nooshin dalili, Assistant Professor, Shahid Beheshti University of Medical SciencesPrincipal Investigator

Lead Sponsor

Shahid Beheshti University of Medical SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
UC Positives	Experimental	Stable Transplanted Patients with Positive UC	Biological: Phage

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Phage	Biological	Inserting specific specimen of phages in to the bladder	UC Positives

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Urine culture	Negative Urine Culture	1 week after administration

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Rejection periods
Frail Patients

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Dalili	SBMU	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Nooshin Dalili		Tehran		1666663421	Iran

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014552	Urinary Tract Infections

Ancestor Terms

ID	Term
D007239	Infections
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided