Clinical trial NCT03211026: Urinary Tract Infections in Kidney Transplant Recipients
Official title: Urinary Tract Infections in Kidney Transplant Recipients : an Observational Cohort
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Kidney Transplantation
Keywords: Urinary tract infection
Multidrug resistant bacteria
Candiduria
Epidemiology
Graft rejection
Solid organ transplantation
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2017-07-07
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male and female

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of UTI due to MDR bacteria
timeFrame: Day 0 to 2 years
Secondary outcomes:
measure: Epidemiology of UTI in KIT recipients
timeFrame: Day 0 to 2 years
measure: Risk factors for MDR UTI
timeFrame: Day 0 to 2 years
measure: Carbapenem use to treat UTI
timeFrame: Day 0 to 2 years
measure: Coherence between antibiotic protocol and treatment received to treat UTI
timeFrame: Day 0 to 2 years
measure: UTI relapse frequency
timeFrame: Day 0 to 2 years
measure: UTI recurrence frequency with a different micororganism
timeFrame: Day 0 to 2 years
measure: Assessment of kidney function during the observation period
timeFrame: Day 0 to 2 years
measure: Graft outcome
timeFrame: Day 0 to 2 years
measure: Patients outcome
timeFrame: Day 0 to 2 years
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CHU de Poitiers
Study officials:
affiliation: Poitiers University Hospital
name: Antoine THIERRY, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Poitiers University Hospital
name: Blandine RAMMAERT
role: STUDY_DIRECTOR
References: