Registry of Febrile Neutropenia and Invasive Fungal Infections

Chang Gung Medical Foundation

Status: Unknown

Conditions: Febrile Neutropenia; Fungal Infections; Hematological Disease

Treatments: Other: Patient registry

Study type: Observational

Funder types: Other

Identifiers

NCT01684189

MISP38887

Details and patient eligibility

About

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

Full description

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.

Enrollment: 100 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

Patient registry

Description:

Patients with newly diagnosed malignant hematological diseases will be enrolled into this registry

Treatment:

Other: Patient registry