The Significance of Funguria in Hospitalized Patients (FACES)
| Tracking Information | |||||
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| First Received Date ICMJE | November 6, 2008 | ||||
| Last Updated Date | November 6, 2008 | ||||
| Start Date ICMJE | September 2001 | ||||
| Primary Completion Date | February 2006 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Funguria [ Time Frame: Hospitalization day 0, 3, 7, 14, and every 7 days thereafter until hospital discharge or death ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Significance of Funguria in Hospitalized Patients | ||||
| Official Title ICMJE | The Significance of Funguria in Hospitalized Patients (FACES) | ||||
| Brief Summary | This investigation is a epidemiologic case-control study of the risk factors associated with nosocomial funguria (fungi in the urine). |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: Urine and blood cultures |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients hospitalized at the Harbor-UCLA Medical Center and Cedars-Sinai Medical Center |
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| Condition ICMJE | Urinary Tract Infections | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 919 | ||||
| Completion Date | February 2006 | ||||
| Primary Completion Date | February 2006 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00787085 | ||||
| Other Study ID Numbers ICMJE | 10024-05, NIH-AI01831 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Loren Gregory Miller, M.D., M.P.H., Principal Investigator, Los Angeles Biomedical Research Institute | ||||
| Study Sponsor ICMJE | Los Angeles Biomedical Research Institute | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Los Angeles Biomedical Research Institute | ||||
| Verification Date | November 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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