NCT03211026

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..

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 4, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 7, 2017

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2022

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 4, 2024

Completed
Last Updated

April 14, 2021

Status Verified

April 1, 2021

Enrollment Period

5 years

First QC Date

June 23, 2017

Last Update Submit

April 13, 2021

Conditions

Keywords

Urinary tract infectionMultidrug resistant bacteriaCandiduriaEpidemiologyGraft rejectionSolid organ transplantation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Epidemiology of UTI in KIT recipients

    Day 0 to 2 years

  • Risk factors for MDR UTI

    Day 0 to 2 years

  • Carbapenem use to treat UTI

    Day 0 to 2 years

  • Coherence between antibiotic protocol and treatment received to treat UTI

    Day 0 to 2 years

  • UTI relapse frequency

    Day 0 to 2 years

  • +4 more secondary outcomes

Interventions

No intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Male and female

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Poitiers

Poitiers, 86000, France

RECRUITING

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Antoine THIERRY, PHD

    Poitiers University Hospital

    PRINCIPAL INVESTIGATOR
  • Blandine RAMMAERT

    Poitiers University Hospital

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2017

First Posted

July 7, 2017

Study Start

May 4, 2017

Primary Completion

May 4, 2022

Study Completion

May 4, 2024

Last Updated

April 14, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

No plan will be sharing with others researchers

Locations