Funguria in Hospitalized Patients
Recruitment status was Active, not recruiting
| Tracking Information | |
|---|---|
| First Received Date ICMJE | August 26, 2005 |
| Last Updated Date | August 26, 2010 |
| Start Date ICMJE | September 2001 |
| Primary Completion Date | Not Provided |
| Current Primary Outcome Measures ICMJE | Not Provided |
| Original Primary Outcome Measures ICMJE | Not Provided |
| Change History | Complete list of historical versions of study NCT00138502 on ClinicalTrials.gov Archive Site |
| 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 | Funguria in Hospitalized Patients |
| Official Title ICMJE | The Significance of Funguria In Hospitalized Patients |
| Brief Summary | The purpose of the study is to test the hypothesis that a subpopulation of patients with candiduria are at significant risk for disseminated disease and would benefit from treatment, while others are at low risk from complications and therefore require no antifungal therapy. |
| Detailed Description | This protocol will attempt to generate a detailed clinical profile of patients with funguria and identify subgroups of patients with funguria at high risk for candiduria and determine the relative risks for obtaining candiduria. In addition, it will look at identifying subgroups of patients with funguria at high risk for candidemia and identifying subgroups of patients with funguria at high risk for death. Finally, it will attempt to determine if funguria independently predicts fungemia or death. Data will be complemented by surveillance of a comparable population without funguria. |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Time Perspective: Prospective |
| Target Follow-Up Duration | Not Provided |
| Biospecimen | Not Provided |
| Sampling Method | Not Provided |
| Study Population | Not Provided |
| Condition ICMJE | Candidiasis |
| Intervention ICMJE | Not Provided |
| Study Group/Cohort (s) | Not Provided |
| 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 | Active, not recruiting |
| Enrollment ICMJE | 926 |
| Completion Date | April 2005 |
| Primary Completion Date | Not Provided |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: 1. Persons with a previously positive urine fungal culture during the current hospital admission. |
| 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 | NCT00138502 |
| Other Study ID Numbers ICMJE | 02-050 |
| Has Data Monitoring Committee | Not Provided |
| Responsible Party | Not Provided |
| Study Sponsor ICMJE | National Institute of Allergy and Infectious Diseases (NIAID) |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | National Institute of Allergy and Infectious Diseases (NIAID) |
| Verification Date | October 2007 |
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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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