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The Impact of Antimicrobial Treatment for Asymptomatic Bacteriuria in Renal Transplant Patients

Primary Purpose

Urinary Tract Infection, Bacteriuria, Renal Transplantation

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
antimicrobial treatment according to in-vitro susceptibility
Sponsored by
Rabin Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Tract Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

Inclusion Criteria:

  • Patients who are ≥1 month and ≤ 12 months after renal transplantation.
  • Positive urine culture defined as ≥ 105 colony forming units (CFU) per milliliter of a known single pathogen.

Exclusion Criteria:

  • Any one of the following signs and symptoms: fever, abdominal pain, dysuria, frequency, urgency, flank pain, costovertebral-angel tenderness or tenderness over the transplanted kidney
  • Active infections in another site
  • Leucocytosis (WBC >18.000K/micl) or leucopenia (WBC < 3.000 K/micl)
  • Elevation of serum creatinine of more than 15% of its baseline level
  • Obstructive or other urological complications following transplantation as known foreign device (stent/double-J-Cath, any catheter) in the urinary tract system, known obstruction of the transplanted kidney, indwelling or intermittent catheterization
  • Pregnant or lactating women.
  • Candidates to invasive urologic procedures.
  • Inability to return for regular follow up.
  • Previous enrollment in this study.
  • Patients who incapable of giving informed consent.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Active Comparator

    Arm Label

    no therapy

    antimicrobial treatment according to in-vitro susceptibility

    Arm Description

    Outcomes

    Primary Outcome Measures

    development of symptomatic urinary tract infection

    Secondary Outcome Measures

    25% reduction in estimated glomerular filtration rate (eGFR)

    Full Information

    First Posted
    March 23, 2014
    Last Updated
    April 14, 2014
    Sponsor
    Rabin Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02113774
    Brief Title
    The Impact of Antimicrobial Treatment for Asymptomatic Bacteriuria in Renal Transplant Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2014
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2014 (undefined)
    Primary Completion Date
    April 2019 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Rabin Medical Center

    4. Oversight

    5. Study Description

    Brief Summary
    The investigators hypothesize that antibiotic therapy for asymptomatic bacteriuria in renal transplant patients does not have impact on the development of symptomatic urinary tract infection (UTI) or progression of renal impairment in patients during the first year after transplantation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Urinary Tract Infection, Bacteriuria, Renal Transplantation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4

    8. Arms, Groups, and Interventions

    Arm Title
    no therapy
    Arm Type
    No Intervention
    Arm Title
    antimicrobial treatment according to in-vitro susceptibility
    Arm Type
    Active Comparator
    Intervention Type
    Other
    Intervention Name(s)
    antimicrobial treatment according to in-vitro susceptibility
    Primary Outcome Measure Information:
    Title
    development of symptomatic urinary tract infection
    Time Frame
    30 days
    Secondary Outcome Measure Information:
    Title
    25% reduction in estimated glomerular filtration rate (eGFR)
    Time Frame
    1 year
    Other Pre-specified Outcome Measures:
    Title
    graft loss
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Eligibility Criteria
    Inclusion Criteria: Patients who are ≥1 month and ≤ 12 months after renal transplantation. Positive urine culture defined as ≥ 105 colony forming units (CFU) per milliliter of a known single pathogen. Exclusion Criteria: Any one of the following signs and symptoms: fever, abdominal pain, dysuria, frequency, urgency, flank pain, costovertebral-angel tenderness or tenderness over the transplanted kidney Active infections in another site Leucocytosis (WBC >18.000K/micl) or leucopenia (WBC < 3.000 K/micl) Elevation of serum creatinine of more than 15% of its baseline level Obstructive or other urological complications following transplantation as known foreign device (stent/double-J-Cath, any catheter) in the urinary tract system, known obstruction of the transplanted kidney, indwelling or intermittent catheterization Pregnant or lactating women. Candidates to invasive urologic procedures. Inability to return for regular follow up. Previous enrollment in this study. Patients who incapable of giving informed consent.

    12. IPD Sharing Statement

    Learn more about this trial

    The Impact of Antimicrobial Treatment for Asymptomatic Bacteriuria in Renal Transplant Patients

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