Registry of Febrile Neutropenia and Invasive Fungal Infections

September 11, 2012 updated by: Chang Gung Memorial Hospital

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 833
        • Recruiting
        • Kaohsiung Chang Gung Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Ming-Chung Wang, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with newly diagnosed malignant hematological diseases

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: Ming-Chung Wang, M.D., Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Study Completion (Anticipated)

August 1, 2013

Study Registration Dates

First Submitted

September 10, 2012

First Submitted That Met QC Criteria

September 11, 2012

First Posted (Estimate)

September 12, 2012

Study Record Updates

Last Update Posted (Estimate)

September 12, 2012

Last Update Submitted That Met QC Criteria

September 11, 2012

Last Verified

November 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MISP38887

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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