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Registry of Febrile Neutropenia and Invasive Fungal Infections

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Chang Gung Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01684189
First received: September 10, 2012
Last updated: September 11, 2012
Last verified: November 2011
  Purpose

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

Condition Intervention
Hematological Disease
Febrile Neutropenia
Fungal Infections
Other: Patient registry

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Estimated Enrollment: 100
Study Start Date: November 2011
Estimated Study Completion Date: August 2013
Groups/Cohorts Assigned Interventions
Patient registry
Patients with newly diagnosed malignant hematological diseases will be enrolled into this registry
Other: Patient registry
Patient registry without study intervention

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with newly diagnosed malignant hematological diseases

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01684189

Contacts
Contact: Ming-Chung Wang, M.D. +886-7-7317123 ext 3266 wang9595@ms32.hinet.net

Locations
Taiwan
Kaohsiung Chang Gung Memorial Hospital Recruiting
Kaohsiung, Taiwan, 833
Contact: Ming-Chung Wang, M.D.    +886-7-7317123 ext 3266    wang9595@ms32.hinet.net   
Principal Investigator: Ming-Chung Wang, M.D.         
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Ming-Chung Wang, M.D. Kaohsiung Chang Gung Memorial Hospital
  More Information

No publications provided

Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01684189     History of Changes
Other Study ID Numbers: MISP38887
Study First Received: September 10, 2012
Last Updated: September 11, 2012
Health Authority: Taiwan : Food and Drug Administration

Additional relevant MeSH terms:
Hematologic Diseases
Communicable Diseases
Febrile Neutropenia
Fever
Infection
Mycoses
Neutropenia
Agranulocytosis
Body Temperature Changes
Leukocyte Disorders
Leukopenia
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014