Urinary Tract Infections in Kidney Transplant Recipients (URIKIT)

Urinary Tract Infections in Kidney Transplant Recipients : an Observational Cohort

The purpose of this study is to better estimate the prevalence of urinary tract infections (UTI) in kidney transplant (KIT) recipients, and especially multidrug resistant (MDR) bacteria. KIT recipients have a higher risk of UTI over the 6 first months following the transplantation. Urine culture was done in a city lab or at hospital. Current data on bacteriuria and candiduria lead mostly to hospital data that are incomplete..

Study Overview

• Status: Recruiting
• Conditions: Kidney Transplantation
• Intervention / Treatment: Other: No intervention

Detailed Description

The risk of UTI after a kidney transplantation is higher than in the general population. MDR bacteria, such as extended spectrum betalactamase (ESBL)-producing enterobacteriaceae or MDR Pseumomoas aeruginosa are emerging threats due to antibiotic selective pressure. Epidemiological data are mostly data from hospital laboratories that do not show a complete overview of the current situation. In addition, the different centers which participated to this study received before the beginning of the study a protocol to avoid carbapenem use. The main objective of this study is to assess the prevalence of MDR bacteria in an adult population of KIT recipients. Through this study, the management of UTI in KIT recipients will be improved. Data on bacteria or yeasts responsible for UTI (identification, resistance profile), antibiotic use, patients' outcome, and graft outcome will be collected.

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

• Study Contact: Name: Isabelle PIRONNEAU; Phone Number: 0549443203; Email: isabelle.pironneau@chu-poitiers.fr
• Study Contact Backup: Name: François ARRIVE; Phone Number: 0630791699; Email: francois.arrive@gmail.com

Study Locations

• France
  • Poitiers, France, 86000
    • Recruiting
    • CHU de Poitiers
    • Contact: Blandine RAMMAERT, PhD; Phone Number: 0549444422; Email: blandine.rammaert.paltrie@univ-poitiers.fr
    • Principal Investigator: Antoine THIERRY, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Male and female

Description

Inclusion criteria

• Age ≥ 18 year-old
• Kidney transplanted for less than 5 years
• First symptomatic episode of UTI with bacteria or yeast
• To have a health insurance

Exclusion criteria

• Asymptomatic bacteriuria or candiduria
• Protected people
• Pregnant women -> 2 bacteria in the urinalysis without external or internal urinary catheter

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of UTI due to MDR bacteria	Proportion of MDR bacteria compared to other bacteria found in urinalysis of symptomatic KIT patients	Day 0 to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Epidemiology of UTI in KIT recipients	Frequency of each bacteria or yeasts responsible for UTI	Day 0 to 2 years
Risk factors for MDR UTI	Comparison of demographic and clinical characteristic of patients who develop an MDR versus a non-MDR UTI	Day 0 to 2 years
Carbapenem use to treat UTI	Proportion of patients who received carbapenem for UTI treatment	Day 0 to 2 years
Coherence between antibiotic protocol and treatment received to treat UTI	Proportion of patients who received carbapenem while responsible bacteria was susceptible to other antibiotics	Day 0 to 2 years
UTI relapse frequency	Proportion of patients with at least one relaspe of UTI with the same bacteria	Day 0 to 2 years
UTI recurrence frequency with a different micororganism	Proportion of patients with more than one UTI during the study period	Day 0 to 2 years
Assessment of kidney function during the observation period	Difference between the initial kidney function (MDRD) and the final kidney function at the end of the observation period	Day 0 to 2 years
Graft outcome	Number of patients needed a dialysis	Day 0 to 2 years
Patients outcome	Number of deaths	Day 0 to 2 years

Collaborators and Investigators

• Sponsor: Poitiers University Hospital
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Antoine THIERRY, PHD, Poitiers University Hospital; Study Director: Blandine RAMMAERT, Poitiers University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2017
• Primary Completion (Anticipated): May 4, 2022
• Study Completion (Anticipated): May 4, 2024

Study Registration Dates

• First Submitted: June 23, 2017
• First Submitted That Met QC Criteria: July 5, 2017
• First Posted (Actual): July 7, 2017

Study Record Updates

• Last Update Posted (Actual): April 14, 2021
• Last Update Submitted That Met QC Criteria: April 13, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Epidemiology; Urinary tract infection; Multidrug resistant bacteria; Candiduria; Graft rejection; Solid organ transplantation
• Additional Relevant MeSH Terms: Urologic Diseases; Infections; Urinary Tract Infections
• Other Study ID Numbers: 2016-A02081-50

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No plan will be sharing with others researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No