Urinary Tract Infections in Kidney Transplant Recipients

NCT ID: NCT03211026

Last Updated: 2021-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-04

Study Completion Date

2024-05-04

Brief Summary

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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

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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.

Conditions

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Kidney Transplantation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Poitiers University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Antoine THIERRY, PHD

Role: PRINCIPAL_INVESTIGATOR

Poitiers University Hospital

Blandine RAMMAERT

Role: STUDY_DIRECTOR

Poitiers University Hospital

Locations

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CHU de Poitiers

Poitiers, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Isabelle PIRONNEAU

Role: CONTACT

0549443203

François ARRIVE

Role: CONTACT

0630791699

Facility Contacts

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Blandine RAMMAERT, PhD

Role: primary

0549444422

Other Identifiers

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2016-A02081-50

Identifier Type: -

Identifier Source: org_study_id

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