NCT01060956

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".

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2010

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2010

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2010

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

July 27, 2011

Status Verified

February 1, 2010

Enrollment Period

1 year

First QC Date

February 1, 2010

Last Update Submit

July 26, 2011

Conditions

Keywords

Urinary tract infection with two bacteria in culture

Outcome Measures

Primary Outcomes (1)

  • Change of antibiotic treatment

    During the episode of urinary tract infection

Secondary Outcomes (3)

  • Days to clinical resolution

    Duration of urinary tract infection and duration of hospitalization

  • Increase/decrease in the spectrum of antibiotic

    Duration of urinary tract infection and duration of hospitalization

  • Length of stay in hospital

    Duration of urinary tract infection and duration of hospitalization

Study Arms (2)

Reporting on two bacteria in urine culture

ACTIVE COMPARATOR

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 "mixed growth"

PLACEBO COMPARATOR

The microbiology laboratory will report on mixed growth in urine culture

Other: reporting "mixed growth" on urine culture

Interventions

reporting of two different bacteria in urine culture

Reporting on two bacteria in urine culture

reporting "mixed growth" on urine culture

reporting "mixed growth"

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Positive blood cultures or no blood cultures taken

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Amos M Yinnon, MD, Prof

    Hebrew university, Jerusalem, Israel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 1, 2010

First Posted

February 2, 2010

Study Start

February 1, 2010

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

July 27, 2011

Record last verified: 2010-02