search
Back to results

The Clinical Impact of Isolation of Two Different Bacteria in Urinary Cultures

Primary Purpose

Urinary Tract Infection

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
reporting of two different bacteria in urine culture
reporting "mixed growth" on urine culture
Sponsored by
Shaare Zedek Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Urinary Tract Infection focused on measuring Urinary tract infection with two bacteria in culture

Eligibility Criteria

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

Inclusion Criteria:

  • Adults hospitalized with indwelling urinary catheter in growth of two bacteria in urine culture

Exclusion Criteria:

  • Positive blood cultures or no blood cultures taken

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Reporting on two bacteria in urine culture

    reporting "mixed growth"

    Arm Description

    The microbiology laboratory will report on the isolation and susceptibilities of two different bacteria in urine culture

    The microbiology laboratory will report on mixed growth in urine culture

    Outcomes

    Primary Outcome Measures

    Change of antibiotic treatment

    Secondary Outcome Measures

    Days to clinical resolution
    Increase/decrease in the spectrum of antibiotic
    Length of stay in hospital

    Full Information

    First Posted
    February 1, 2010
    Last Updated
    July 26, 2011
    Sponsor
    Shaare Zedek Medical Center
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01060956
    Brief Title
    The Clinical Impact of Isolation of Two Different Bacteria in Urinary Cultures
    Official Title
    The Clinical Impact of Isolation of Two Different Bacteria in Urinary Cultures
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2010 (undefined)
    Primary Completion Date
    February 2011 (Actual)
    Study Completion Date
    February 2011 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Shaare Zedek Medical Center

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to determine whether identification of two different bacteria in urine culture of patients with indwelling catheter has a clinical impact - change in antibiotic, duration of antibiotic, days to clinical resolution and length of stay in hospital. The microbiology laboratory will randomized urine cultures with two bacteria from indwelling catheter to either reporting identity and susceptibility of the bacteria or reporting "mixed growth".

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Urinary Tract Infection
    Keywords
    Urinary tract infection with two bacteria in culture

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    81 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Reporting on two bacteria in urine culture
    Arm Type
    Active Comparator
    Arm Description
    The microbiology laboratory will report on the isolation and susceptibilities of two different bacteria in urine culture
    Arm Title
    reporting "mixed growth"
    Arm Type
    Placebo Comparator
    Arm Description
    The microbiology laboratory will report on mixed growth in urine culture
    Intervention Type
    Other
    Intervention Name(s)
    reporting of two different bacteria in urine culture
    Intervention Description
    reporting of two different bacteria in urine culture
    Intervention Type
    Other
    Intervention Name(s)
    reporting "mixed growth" on urine culture
    Intervention Description
    reporting "mixed growth" on urine culture
    Primary Outcome Measure Information:
    Title
    Change of antibiotic treatment
    Time Frame
    During the episode of urinary tract infection
    Secondary Outcome Measure Information:
    Title
    Days to clinical resolution
    Time Frame
    Duration of urinary tract infection and duration of hospitalization
    Title
    Increase/decrease in the spectrum of antibiotic
    Time Frame
    Duration of urinary tract infection and duration of hospitalization
    Title
    Length of stay in hospital
    Time Frame
    Duration of urinary tract infection and duration of hospitalization

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adults hospitalized with indwelling urinary catheter in growth of two bacteria in urine culture Exclusion Criteria: Positive blood cultures or no blood cultures taken
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Amos M Yinnon, MD, Prof
    Organizational Affiliation
    Hebrew university, Jerusalem, Israel
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    The Clinical Impact of Isolation of Two Different Bacteria in Urinary Cultures

    We'll reach out to this number within 24 hrs