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Prospective Comparative Study About Treatment of Asymptomatic Bacteriuria in Kidney Transplant Recipients.

Primary Purpose

Asymptomatic Bacteriuria

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Antibiotic adjusted to antibiogram
Sponsored by
López-Medrano, Francisco, M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Asymptomatic Bacteriuria focused on measuring Asymptomatic Bacteriuria, Kidney transplant recipients, Pyelonephritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult patients developing asymptomatic bacteriuria beyond 2 months after transplantation.

Exclusion Criteria:

  • <18 years old
  • Pregnant women
  • Kidney-pancreas transplantation
  • Double J stent catheterization at the momento of randomization
  • Permanent vesical catheter

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    A: Antibiotic adjusted to antibiogram

    B: no treatment

    Arm Description

    A course of 3-14 days of antimicrobial treatment, according to the antibiogram results, will be prescribed for every episode of asymptomatic bacteriuria beyond 2 months after transplantation and during the first 2 years after transplantation

    No treatment of any episode of asymptomatic bacteriuria beyond 2 months after transplantation in kidney transplant recipients.

    Outcomes

    Primary Outcome Measures

    Incidence of Pyelonephritis
    The number of patients that develope pyelonephritis in the first 2 years after transplantation in each group, divided by the number of patients allocated in each group at randomization.

    Secondary Outcome Measures

    Incidence of lower tract urinary infection
    The number of patients that develope lower tract urinary infection in the first 2 years after transplantation in each group, divided by the number of patients allocated in each group at randomization.
    Incidence of Clostridium difficile infection
    The number of patients that develope Clostridium difficile infection in the first 2 years after transplantation in each group, divided by the number of patients allocated in each group at randomization.
    Incidence of multidrug resistant bacteria colonization/infection
    The number of patients that develope multidrug resistant bacteria colonization/infection in the first 2 years after transplantation in each group, divided by the number of patients allocated in each group at randomization.
    Long-term graft function
    Long-term graft function measured by average serum creatinine at several points until the end of follow-up.

    Full Information

    First Posted
    February 13, 2015
    Last Updated
    February 20, 2015
    Sponsor
    López-Medrano, Francisco, M.D.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02373085
    Brief Title
    Prospective Comparative Study About Treatment of Asymptomatic Bacteriuria in Kidney Transplant Recipients.
    Official Title
    Effect of Systematic Search and Antimicrobial Treatment of Asymptomatic Bacteriuria in Kidney Transplant Recipients in the Incidence of Acute Pyelonephritis: a Pragmatic Prospective Randomized Controlled Study.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2011 (undefined)
    Primary Completion Date
    August 2014 (Actual)
    Study Completion Date
    January 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    López-Medrano, Francisco, M.D.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Antimicrobial treatment of asymptomatic bacteriuria (AB) in kidney transplant recipients (KTR) is controversial. The investigators performed a comparative, parallel-group, randomized, open-label study to assess, in a real clinical setting, the feasibility of and benefit derived from systematic search and antimicrobial treatment of all episodes of AB.
    Detailed Description
    All patients undergoing KT between January 2011 and December 2013 in a tertiary-care center with an active transplantation program were systematically searched for AB within the first 2 years after transplantation on a regular basis. During the first 2 months after transplantation all episodes of AB were treated. Thereafter, patients were assigned, according to a computer-generated randomization sequence, to group A (systematic antimicrobial treatment of all episodes of AB) or group B (no treatment). Treatment was chosen according to the results of the urine culture.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asymptomatic Bacteriuria
    Keywords
    Asymptomatic Bacteriuria, Kidney transplant recipients, Pyelonephritis

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    112 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    A: Antibiotic adjusted to antibiogram
    Arm Type
    Experimental
    Arm Description
    A course of 3-14 days of antimicrobial treatment, according to the antibiogram results, will be prescribed for every episode of asymptomatic bacteriuria beyond 2 months after transplantation and during the first 2 years after transplantation
    Arm Title
    B: no treatment
    Arm Type
    No Intervention
    Arm Description
    No treatment of any episode of asymptomatic bacteriuria beyond 2 months after transplantation in kidney transplant recipients.
    Intervention Type
    Other
    Intervention Name(s)
    Antibiotic adjusted to antibiogram
    Other Intervention Name(s)
    Anti-infective agents
    Intervention Description
    A course of 3-14 days of antimicrobial treatment, according to the antibiogram results, will be prescribed for every episode of asymptomatic bacteriuria during the first 2 years after transplantation.
    Primary Outcome Measure Information:
    Title
    Incidence of Pyelonephritis
    Description
    The number of patients that develope pyelonephritis in the first 2 years after transplantation in each group, divided by the number of patients allocated in each group at randomization.
    Time Frame
    2 years after transplantation
    Secondary Outcome Measure Information:
    Title
    Incidence of lower tract urinary infection
    Description
    The number of patients that develope lower tract urinary infection in the first 2 years after transplantation in each group, divided by the number of patients allocated in each group at randomization.
    Time Frame
    2 years after transplantation
    Title
    Incidence of Clostridium difficile infection
    Description
    The number of patients that develope Clostridium difficile infection in the first 2 years after transplantation in each group, divided by the number of patients allocated in each group at randomization.
    Time Frame
    2 years after transplantation
    Title
    Incidence of multidrug resistant bacteria colonization/infection
    Description
    The number of patients that develope multidrug resistant bacteria colonization/infection in the first 2 years after transplantation in each group, divided by the number of patients allocated in each group at randomization.
    Time Frame
    2 years after transplantation
    Title
    Long-term graft function
    Description
    Long-term graft function measured by average serum creatinine at several points until the end of follow-up.
    Time Frame
    At 1 year and 2 years after transplantation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult patients developing asymptomatic bacteriuria beyond 2 months after transplantation. Exclusion Criteria: <18 years old Pregnant women Kidney-pancreas transplantation Double J stent catheterization at the momento of randomization Permanent vesical catheter
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Francisco López-Medrano, MD,PhD
    Organizational Affiliation
    López-Medrano, Francisco, M.D.
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27088545
    Citation
    Origuen J, Lopez-Medrano F, Fernandez-Ruiz M, Polanco N, Gutierrez E, Gonzalez E, Merida E, Ruiz-Merlo T, Morales-Cartagena A, Perez-Jacoiste Asin MA, Garcia-Reyne A, San Juan R, Orellana MA, Andres A, Aguado JM. Should Asymptomatic Bacteriuria Be Systematically Treated in Kidney Transplant Recipients? Results From a Randomized Controlled Trial. Am J Transplant. 2016 Oct;16(10):2943-2953. doi: 10.1111/ajt.13829. Epub 2016 May 23.
    Results Reference
    derived

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    Prospective Comparative Study About Treatment of Asymptomatic Bacteriuria in Kidney Transplant Recipients.

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