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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01060956
First Posted: February 2, 2010
Last Update Posted: July 27, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Shaare Zedek Medical Center
  Purpose

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".


Condition Intervention
Urinary Tract Infection Other: reporting of two different bacteria in urine culture Other: reporting "mixed growth" on urine culture

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: The Clinical Impact of Isolation of Two Different Bacteria in Urinary Cultures

Resource links provided by NLM:


Further study details as provided by Shaare Zedek Medical Center:

Primary Outcome Measures:
  • Change of antibiotic treatment [ Time Frame: During the episode of urinary tract infection ]

Secondary Outcome Measures:
  • Days to clinical resolution [ Time Frame: 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 ]
  • Length of stay in hospital [ Time Frame: Duration of urinary tract infection and duration of hospitalization ]

Enrollment: 81
Study Start Date: February 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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): NCT01060956


Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
Principal Investigator: Amos M Yinnon, MD, Prof Hebrew university, Jerusalem, Israel
  More Information

Responsible Party: Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT01060956     History of Changes
Other Study ID Numbers: UTI1
First Submitted: February 1, 2010
First Posted: February 2, 2010
Last Update Posted: July 27, 2011
Last Verified: February 2010

Keywords provided by Shaare Zedek Medical Center:
Urinary tract infection with two bacteria in culture

Additional relevant MeSH terms:
Urinary Tract Infections
Infection
Urologic Diseases