The Significance of Funguria in Hospitalized Patients (FACES)

This study has been completed.
Sponsor:
Collaborators:
Cedars-Sinai Medical Center
Information provided by:
Los Angeles Biomedical Research Institute
ClinicalTrials.gov Identifier:
NCT00787085
First received: November 6, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted
  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

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

Resource links provided by NLM:


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

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
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: NCT00787085

Locations
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Harbor-UCLA Medical Center
Torrance, California, United States, 90509
Sponsors and Collaborators
Los Angeles Biomedical Research Institute
Cedars-Sinai Medical Center
Investigators
Principal Investigator: Loren G Miller, M.D., M.P.H. Los Angeles Biomedical Research Institute
  More Information

No publications provided

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

Keywords provided by Los Angeles Biomedical Research Institute:
Funguria
Epidemiology
Urinary Tract Infections

Additional relevant MeSH terms:
Urinary Tract Infections
Infection
Urologic Diseases

ClinicalTrials.gov processed this record on August 28, 2014