Febrile Neutropenia Clinical Trial
Official title:
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
Objectives：
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
Objectives：
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.
;
Observational Model: Case-Only, Time Perspective: Prospective
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