Registry of Febrile Neutropenia and Invasive Fungal Infections

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01684189
• Other study ID #: MISP38887
• Status: Recruiting
• Phase: N/A
• First received: September 10, 2012
• Last updated: September 11, 2012
• Start date: November 2011
• Est. completion date: August 2013

Study information

• Verified date: November 2011
• Source: Chang Gung Memorial Hospital
• Contact: Ming-Chung Wang, M.D.
• Phone: +886-7-7317123
• Email: wang9595[@]ms32.hinet.net
• Is FDA regulated: No
• Health authority: Taiwan : Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Febrile Neutropenia
• Fever
• Fungal Infections
• Hematologic Diseases
• Hematological Disease
• Infection
• Mycoses
• Neutropenia

Intervention

Other:
• Patient registry
Patient registry without study intervention

Locations

Country	Name	City	State
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan,