Back to resultsTreatment Chronic UTI Post Kidney Transplant
Primary Purpose
Urinary Tract Infections, Transplant-Related Disorder
Status
Recruiting
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Phage
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Tract Infections
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
Sites / Locations
- Nooshin DaliliRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
UC Positives
Arm Description
Stable Transplanted Patients with Positive UC
Outcomes
Primary Outcome Measures
Urine culture
Negative Urine Culture
Secondary Outcome Measures
Full Information
NCT ID
NCT05967130
First Posted
July 15, 2023
Last Updated
July 21, 2023
Sponsor
Shahid Beheshti University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05967130
Brief Title
Treatment Chronic UTI Post Kidney Transplant
Official Title
Treatment of Chronic Relapsing Urinary Tract Infection With Bacteriophages in Renal Transplant Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infections, Transplant-Related Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
UC Positives
Arm Type
Experimental
Arm Description
Stable Transplanted Patients with Positive UC
Intervention Type
Biological
Intervention Name(s)
Phage
Intervention Description
Inserting specific specimen of phages in to the bladder
Primary Outcome Measure Information:
Title
Urine culture
Description
Negative Urine Culture
Time Frame
1 week after administration
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dalili
Phone
00989122404331
Ext
0098
Email
dr.nooshindalili@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dalili
Organizational Affiliation
SBMU
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nooshin Dalili
City
Tehran
ZIP/Postal Code
1666663421
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nooshin Dalili, Dr
Phone
00989122404331
Email
nooshindalili4@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Treatment Chronic UTI Post Kidney Transplant
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