Urinary Tract Infections in Kidney Transplant Recipients

Kidney Transplantation Clinical Trial

— URIKIT  

Official title:

Urinary Tract Infections in Kidney Transplant Recipients : an Observational Cohort

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03211026
• Other study ID #: 2016-A02081-50
• Status: Recruiting
• Start date: May 4, 2017
• Est. completion date: May 4, 2024

Study information

• Verified date: April 2021
• Source: Poitiers University Hospital
• Contact: Isabelle PIRONNEAU
• Phone: 0549443203
• Email: isabelle.pironneau[@]chu-poitiers.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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..

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: May 4, 2024
• Est. primary completion date: May 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infection
• Kidney Transplantation
• Urinary Tract Infections

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
France	CHU de Poitiers	Poitiers

Sponsors (2)

Lead Sponsor	Collaborator
Poitiers University Hospital	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Epidemiology of UTI in KIT recipients	Frequency of each bacteria or yeasts responsible for UTI	Day 0 to 2 years
Secondary	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
Secondary	Carbapenem use to treat UTI	Proportion of patients who received carbapenem for UTI treatment	Day 0 to 2 years
Secondary	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
Secondary	UTI relapse frequency	Proportion of patients with at least one relaspe of UTI with the same bacteria	Day 0 to 2 years
Secondary	UTI recurrence frequency with a different micororganism	Proportion of patients with more than one UTI during the study period	Day 0 to 2 years
Secondary	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
Secondary	Graft outcome	Number of patients needed a dialysis	Day 0 to 2 years
Secondary	Patients outcome	Number of deaths	Day 0 to 2 years