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Registry of Febrile Neutropenia and Invasive Fungal Infections

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01684189
Enrollment
100
Registered
2012-09-12
Start date
2011-11-30
Completion date
2013-08-31
Last updated
2012-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Febrile Neutropenia, Fungal Infections, Hematological Disease

Brief 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

Detailed 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.

Interventions

Patient registry without study intervention

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Countries

Taiwan

Contacts

Primary ContactMing-Chung Wang, M.D.
wang9595@ms32.hinet.net+886-7-7317123

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026