Registry of Febrile Neutropenia and Invasive Fungal Infections

Sponsor

Chang Gung Memorial Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01684189

Collaborator

(none)

100

Enrollment

Location

Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hematological Disease Febrile Neutropenia Fungal Infections	Other: Patient registry

Detailed Description

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

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

Study Start Date :

Nov 1, 2011

Anticipated Study Completion Date :

Aug 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Patient registry Patients with newly diagnosed malignant hematological diseases will be enrolled into this registry	Other: Patient registry Patient registry without study intervention

Arm

Intervention/Treatment

Patient registry

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

Other: Patient registry

Patient registry without study intervention

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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