Registry of Febrile Neutropenia and Invasive Fungal Infections

Study Overview
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Brief Summary
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Objectives： To assess the percentage of febrile neutropenia and suspected fungal-related febrile episodes in patients receiving chemotherapy To explore the percentage/distribution of infectious origins of febrile neutropenia To explore the percentage/distribution of infectious pathogens of febrile neutropenia To explore clinical outcomes of different infectious origins/pathogens in febrile neutropenia episodes 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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Objectives： To assess the percentage of febrile neutropenia and suspected fungal-related febrile episodes in patients receiving chemotherapy To explore the percentage/distribution of infectious origins of febrile neutropenia To explore the percentage/distribution of infectious pathogens of febrile neutropenia To explore clinical outcomes of different infectious origins/pathogens in febrile neutropenia episodes 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.

Official Title
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A Non-interventional Prospective Registry to Monitor the Events of Febrile Neutropenia and Invasive Fungal Infections and the Diagnostic and Therapeutic Management in Patients With Malignant Hematologic Diseases After Chemotherapy

Conditions
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Hematological Disease, Febrile Neutropenia, Fungal Infections

Intervention / Treatment
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* Other: Patient registry


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with new diagnosed hematological diseases (acute and chronic myeloid and lymphoid leukemia, multiple myeloma, non-Hodgkin's and Hodgkin's lymphoma, myelodysplastic syndromes) Patients who are receiving chemotherapy and have ongoing febrile episodes Exclusion Criteria: None
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient registry<br>Patients with newly diagnosed malignant hematological diseases will be enrolled into this registry | Other: Patient registry<br>* Patient registry without study intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |