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

This study has been completed.
Sponsor:
Information provided by:
Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT01060956
First received: February 1, 2010
Last updated: July 26, 2011
Last verified: February 2010
  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 Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Days to clinical resolution [ Time Frame: Duration of urinary tract infection and duration of hospitalization ] [ Designated as safety issue: Yes ]
  • Increase/decrease in the spectrum of antibiotic [ Time Frame: Duration of urinary tract infection and duration of hospitalization ] [ Designated as safety issue: Yes ]
  • Length of stay in hospital [ Time Frame: Duration of urinary tract infection and duration of hospitalization ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01060956

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

No publications provided

Responsible Party: Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT01060956     History of Changes
Other Study ID Numbers: UTI1
Study First Received: February 1, 2010
Last Updated: July 26, 2011
Health Authority: Israel: Ethics Commission

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

Additional relevant MeSH terms:
Infection
Urinary Tract Infections
Urologic Diseases

ClinicalTrials.gov processed this record on October 23, 2014