Urinary Tract Infections in Kidney Transplant Recipients

• Conditions: Kidney Transplantation

• Registration Number: NCT03211026
• Lead Sponsor: Poitiers University Hospital

Brief Summary

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..

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 Timeline

• Study Start: 2017-05-04
• Study First Submitted: 2017-06-23
• Study First Submitted QC: 2017-07-05
• Study First Posted: 2017-07-07
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-13
• Last Update Posted: 2021-04-14
• Primary Completion: 2022-05-04
• Study Completion: 2024-05-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of UTI due to MDR bacteria	Day 0 to 2 years	Proportion of MDR bacteria compared to other bacteria found in urinalysis of symptomatic KIT patients

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU de Poitiers; 🇫🇷 Poitiers, France