CClinicalTrials.gg
Status unknownNCT01684189Updated Sep 12, 2012

Registry of Febrile Neutropenia and Invasive Fungal Infections

An observational study in Hematological Disease, Febrile Neutropenia and Fungal Infections, sponsored by Chang Gung Memorial Hospital. Status unknown at 1 site in Taiwan. Per ClinicalTrials.gov, last updated 2012-09-12.

Sponsored by Chang Gung Memorial Hospital · Observational

The sponsor has not verified this record recently (last verified Nov 2011), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
100
Sex
All
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Study 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
Read the 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.

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Conditions studied

03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's planned enrollment of 100 is below the median of 240 across 2,136 observational studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with newly diagnosed malignant hematological diseases

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

Exclusion Criteria:

  • None
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
100 participants (estimated)

Groups and cohorts

  • Patient registry

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

    Other: Patient registry

Interventions

  • OtherPatient registry

    Patient registry without study intervention

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Study locations

1 of 1 sites recruiting
  • Kaohsiung Chang Gung Memorial Hospital
    Kaohsiung, 833, Taiwan
    • Ming-Chung Wang, M.D. · Contact · wang9595@ms32.hinet.net · +886-7-7317123
    • Ming-Chung Wang, M.D. · Principal investigator
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 12, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01684189
Lead sponsor
Chang Gung Memorial Hospital
Responsible party
Sponsor
First posted
Sep 12, 2012
Start date
Nov 2011
Completion
Aug 2013 (estimated)
Last update
Sep 12, 2012

Study contacts

Ming-Chung Wang, M.D.
Contact
wang9595@ms32.hinet.net
+886-7-7317123 ext. 3266
Ming-Chung Wang, M.D.
principal investigator · Chang Gung Memorial Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.

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