Invasive Fungal Infections Surveillance Initiative
| Tracking Information | |||||
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| First Received Date ICMJE | September 13, 2005 | ||||
| Last Updated Date | January 15, 2013 | ||||
| Start Date ICMJE | August 2005 | ||||
| Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
outcome after invasive fungal infection [ Time Frame: 60 days post infection ] [ Designated as safety issue: No ] outcome after invasive fungal infection |
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| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00177944 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 | Invasive Fungal Infections Surveillance Initiative | ||||
| Official Title ICMJE | Invasive Fungal Infections Surveillance Initiative | ||||
| Brief Summary | The purpose of this study is to optimize the management of patients treated for invasive fungal infections by establishing a real-time, continuous clinical data base that will capture and monitor trends in the epidemiology, diagnosis, treatment and outcomes of invasive fungal infections; reflect routine clinical management of patients with invasive fungal infections in order to evaluate treatment and provide a rationale for future treatment paradigms; and allow physicians to assess adherence to institutional clinical practice guidelines, validate current standardized definitions for patients with invasive fungal infections and promote change where appropriate. |
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| Detailed Description | Gender, height, weight, ethnicity, antifungal treatment, fungal colonization, laboratory results, past medical history, invasive fungal infection diagnosis, medications, outcomes |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | patients with funal infections |
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| Condition ICMJE | Fungal Infection | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | patients with funal infections | ||||
| 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 | 172 | ||||
| Completion Date | August 2012 | ||||
| Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| 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 | NCT00177944 | ||||
| Other Study ID Numbers ICMJE | IRB # 0503062 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | University of Pittsburgh | ||||
| Study Sponsor ICMJE | University of Pittsburgh | ||||
| Collaborators ICMJE | Astellas Pharma US, Inc. | ||||
| Investigators ICMJE |
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| Information Provided By | University of Pittsburgh | ||||
| Verification Date | January 2013 | ||||
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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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