Registry of Febrile Neutropenia and Invasive Fungal Infections
NCT ID: NCT01684189
Last Updated: 2012-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2011-11-30
2013-08-31
Brief Summary
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1. To assess the percentage of febrile neutropenia and suspected fungal-related febrile episodes in patients receiving chemotherapy
2. To explore the percentage/distribution of infectious origins of febrile neutropenia
3. To explore the percentage/distribution of infectious pathogens of febrile neutropenia
4. To explore clinical outcomes of different infectious origins/pathogens in febrile neutropenia episodes
5. To have a clear view of therapeutic actions in the management of hematological patients with febrile neutropenia and suspected fungal-related febrile episodes
Detailed Description
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1. To assess the percentage of febrile neutropenia and suspected fungal-related febrile episodes in patients receiving chemotherapy
2. To explore the percentage/distribution of infectious origins of febrile neutropenia
3. To explore the percentage/distribution of infectious pathogens of febrile neutropenia
4. To explore clinical outcomes of different infectious origins/pathogens in febrile neutropenia episodes
5. To have a clear view of therapeutic actions in the management of hematological patients with febrile neutropenia and suspected fungal-related febrile episodes
Study Design：
* This is a single institute, prospective, non-interventional registry for monitoring events of febrile neutropenia in hematological patients
* Patients with newly diagnosed malignant hematological diseases will be enrolled into this registry
Study Procedures： Data collection will include patients' basic information, underlying disease, baseline blood chemistry and blood cell counts, antifungal prophylaxis, C/T regimens, neutrophils and other blood cells, fever diagnosis and infectious sites work-up, clinical response, microbiology (including bacteria and fungus culture), renal and liver function, clinical diagnosis, work-up and intensive procedures and results, antifungal and antibacterial agents (including dosage, duration, and route), other drugs used (including antivirals, antineoplastics, corticosteroids, immunomodulators), clinical significant changes
Sample Size Calculation and Statistical Analysis： Approximately 100 febrile neutropenia episodes in 500 chemotherapy cycles will be collected. This is an observational and exploratory study without hypothesis tests. Study subjects will be collected and monitored under normal clinical practice, and the sample size will be limited due to the hospital scale and disease characteristic (the sample size calculation is inapplicable here). All evaluations will be shown by exploratory and descriptive data analysis. The number of cases for each investigative definition, the corresponding percentage and the 95% confidence interval will be described.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Patient registry
Patients with newly diagnosed malignant hematological diseases will be enrolled into this registry
Patient registry
Patient registry without study intervention
Interventions
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Patient registry
Patient registry without study intervention
Eligibility Criteria
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Inclusion Criteria
* Patients who are receiving chemotherapy and have ongoing febrile episodes
Exclusion Criteria
ALL
No
Sponsors
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Chang Gung Memorial Hospital
OTHER
Responsible Party
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Principal Investigators
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Ming-Chung Wang, M.D.
Role: PRINCIPAL_INVESTIGATOR
Chang Gung Memorial Hospital
Locations
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Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Ming-Chung Wang, M.D.
Role: primary
Other Identifiers
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MISP38887
Identifier Type: -
Identifier Source: org_study_id