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Trial record 58 of 159 for:    Urinary Tract Infections | Recruiting, Not yet recruiting, Available Studies | "Communicable Diseases"

Urinary Tract Infections in Kidney Transplant Recipients (URIKIT)

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ClinicalTrials.gov Identifier: NCT03211026
Recruitment Status : Recruiting
First Posted : July 7, 2017
Last Update Posted : November 26, 2018
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
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..

Condition or disease Intervention/treatment
Kidney Transplantation Other: No intervention

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.

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Urinary Tract Infections in Kidney Transplant Recipients : an Observational Cohort
Actual Study Start Date : March 13, 2017
Estimated Primary Completion Date : March 13, 2021
Estimated Study Completion Date : June 13, 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: No intervention
    No intervention


Primary Outcome Measures :
  1. Assessment of UTI due to MDR bacteria [ Time Frame: Day 0 to 2 years ]
    Proportion of MDR bacteria compared to other bacteria found in urinalysis of symptomatic KIT patients


Secondary Outcome Measures :
  1. Epidemiology of UTI in KIT recipients [ Time Frame: Day 0 to 2 years ]
    Frequency of each bacteria or yeasts responsible for UTI

  2. Risk factors for MDR UTI [ Time Frame: Day 0 to 2 years ]
    Comparison of demographic and clinical characteristic of patients who develop an MDR versus a non-MDR UTI

  3. Carbapenem use to treat UTI [ Time Frame: Day 0 to 2 years ]
    Proportion of patients who received carbapenem for UTI treatment

  4. Coherence between antibiotic protocol and treatment received to treat UTI [ Time Frame: Day 0 to 2 years ]
    Proportion of patients who received carbapenem while responsible bacteria was susceptible to other antibiotics

  5. UTI relapse frequency [ Time Frame: Day 0 to 2 years ]
    Proportion of patients with at least one relaspe of UTI with the same bacteria

  6. UTI recurrence frequency with a different micororganism [ Time Frame: Day 0 to 2 years ]
    Proportion of patients with more than one UTI during the study period

  7. Assessment of kidney function during the observation period [ Time Frame: Day 0 to 2 years ]
    Difference between the initial kidney function (MDRD) and the final kidney function at the end of the observation period

  8. Graft outcome [ Time Frame: Day 0 to 2 years ]
    Number of patients needed a dialysis

  9. Patients outcome [ Time Frame: Day 0 to 2 years ]
    Number of deaths



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Male and female
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03211026


Contacts
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Contact: Isabelle PIRONNEAU 0549443203 isabelle.pironneau@chu-poitiers.fr
Contact: François ARRIVE 0630791699 francois.arrive@gmail.com

Locations
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France
CHU de Poitiers Recruiting
Poitiers, France, 86000
Contact: Blandine RAMMAERT, PhD    0549444422    blandine.rammaert.paltrie@univ-poitiers.fr   
Principal Investigator: Antoine THIERRY, PhD         
Sponsors and Collaborators
Poitiers University Hospital
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Antoine THIERRY, PHD Poitiers University Hospital
Study Director: Blandine RAMMAERT Poitiers University Hospital

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Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT03211026     History of Changes
Other Study ID Numbers: 2016-A02081-50
First Posted: July 7, 2017    Key Record Dates
Last Update Posted: November 26, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan will be sharing with others researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Poitiers University Hospital:
Urinary tract infection
Multidrug resistant bacteria
Candiduria
Epidemiology
Graft rejection
Solid organ transplantation

Additional relevant MeSH terms:
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Infection
Urinary Tract Infections
Urologic Diseases