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

July 26, 2011 updated by: Shaare Zedek Medical Center

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".

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Reporting on two bacteria in urine culture
The microbiology laboratory will report on the isolation and susceptibilities of two different bacteria in urine culture
Other: reporting of two different bacteria in urine culture
reporting of two different bacteria in urine culture
PLACEBO_COMPARATOR: reporting "mixed growth"
The microbiology laboratory will report on mixed growth in urine culture
Other: reporting "mixed growth" on urine culture
reporting "mixed growth" on urine culture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of antibiotic treatment
Time Frame: During the episode of urinary tract infection
During the episode of urinary tract infection

Secondary Outcome Measures

Outcome Measure
Time Frame
Days to clinical resolution
Time Frame: Duration of urinary tract infection and duration of hospitalization
Duration of urinary tract infection and duration of hospitalization
Increase/decrease in the spectrum of antibiotic
Time Frame: Duration of urinary tract infection and duration of hospitalization
Duration of urinary tract infection and duration of hospitalization
Length of stay in hospital
Time Frame: Duration of urinary tract infection and duration of hospitalization
Duration of urinary tract infection and duration of hospitalization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shaare Zedek Medical Center

Investigators

  • Principal Investigator: Amos M Yinnon, MD, Prof, Hebrew university, Jerusalem, Israel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (ACTUAL)

February 1, 2011

Study Completion (ACTUAL)

February 1, 2011

Study Registration Dates

First Submitted

February 1, 2010

First Submitted That Met QC Criteria

February 1, 2010

First Posted (ESTIMATE)

February 2, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

July 27, 2011

Last Update Submitted That Met QC Criteria

July 26, 2011

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UTI1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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