The Significance of Funguria in Hospitalized Patients - Full Text View

Sponsors and Collaborators:	Los Angeles Biomedical Research Institute National Institute of Allergy and Infectious Diseases (NIAID) Cedars-Sinai Medical Center
Information provided by:	Los Angeles Biomedical Research Institute
ClinicalTrials.gov Identifier:	NCT00787085

Purpose

This investigation is a epidemiologic case-control study of the risk factors associated with nosocomial funguria (fungi in the urine).

Condition
Urinary Tract Infections

MedlinePlus related topics: Urinary Tract Infections

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	The Significance of Funguria in Hospitalized Patients (FACES)

Further study details as provided by Los Angeles Biomedical Research Institute:

Primary Outcome Measures:

Funguria [ Time Frame: Hospitalization day 0, 3, 7, 14, and every 7 days thereafter until hospital discharge or death ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Urine and blood cultures

Enrollment:	919
Study Start Date:	September 2001
Study Completion Date:	February 2006
Primary Completion Date:	February 2006 (Final data collection date for primary outcome measure)

Groups/Cohorts
Case Patients hospitalized with a urine or blood culture positive for fungi
Control Patients hospitalized with a urine culture negative for fungi

Detailed Description:

A recent large multi-center national surveillance survey of almost 5000 nosocomial (hospital based) urine isolates from medical intensive care units demonstrated that fungi comprised nearly 40% of urine isolates. Little is known about distinguishing fungi that cause colonization from those causing infection.

The objective of this study is to define the epidemiology of nosocomial funguria and natural history of patients that develop funguria while hospitalized.

Patients who may have eligible for this study will be identified from microbiology laboratory specimens at the Harbor-UCLA Medical Center and Cedars-Sinai Medical Center.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients hospitalized at the Harbor-UCLA Medical Center and Cedars-Sinai Medical Center

Criteria

Inclusion Criteria:

Patients hospitalized at least 12 hours of any age (< 1 day to > 100 years of age) AND a urine or blood culture positive for fungi, OR urine culture negative for fungi (control group)

Exclusion Criteria:

Patients already surveyed for funguria during current hospitalization and patients already being followed for recognized funguria

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00787085

Locations

United States, California
Harbor-UCLA Medical Center
Torrance, California, United States, 90509
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048

Sponsors and Collaborators

Los Angeles Biomedical Research Institute

National Institute of Allergy and Infectious Diseases (NIAID)

Cedars-Sinai Medical Center

Investigators

Principal Investigator:

Loren G Miller, M.D., M.P.H.

Los Angeles Biomedical Research Institute

More Information

Responsible Party:	Los Angeles Biomedical Research Institute ( Loren Gregory Miller, M.D., M.P.H., Principal Investigator )
Study ID Numbers:	10024-05, NIH-AI01831
Study First Received:	November 6, 2008
Last Updated:	November 6, 2008
ClinicalTrials.gov Identifier:	NCT00787085
Health Authority:	United States: Institutional Review Board; United States: Federal Government

Keywords provided by Los Angeles Biomedical Research Institute:

Funguria
Epidemiology
Urinary Tract Infections

Study placed in the following topic categories:

Urologic Diseases
Facies
Urinary Tract Infections

Additional relevant MeSH terms:

Infection

ClinicalTrials.gov processed this record on January 16, 2009