Retrospective Observation of Empirical Antifungal Therapy With Itraconazole
20 Years
N/A
Both
Neutropenia
Trial Information
Retrospective Observation of Empirical Antifungal Therapy With Itraconazole
This is a retrospective study ie, a study that looks backward in time, usually using medical
records and interviews with patients who are already known to have a disease, in patients
with itraconazole intravenous prescription as an empirical (based on practical experience)
antifungal agent. This study collects baseline information about underlying disease, sign of
fungal infection, neutropenia (a decrease in white blood cells), neutropenic fever duration
and the reason for discontinuation. Neutropenia is defined as a neutrophil (white blood
cell) count of ≤500 cells/mm3 or a count of ≤1000 cells/mm3 with a predicted decrease to
≤500 cells/mm3. Fever is defined as a body temperature ≥38.3 Celsius degrees at least once a
day with no definite external factor or a body temperature of ≥38 Celsius degrees continued
for at least 1 hour.
Inclusion Criteria:
- Patients with neutropenic fever who receive therapy for inhibiting or preventing
development of neoplasms (abnormal growth of tissue) or stem cell transplantation
(stem cell is a cell whose daughter cells may differentiate into other cell types)
for hematologic malignancies (cancers that affect blood, bone marrow and lymph nodes)
- Patients who receive itraconazole intravenous (IV) treatment for more than 7 days
Exclusion Criteria:
- Childbearing women who are pregnant or likely to be pregnant during the study period
and men who are neither infertile nor willing to refrain from sexual relations but
whose partner does not conduct an effective contraception
- Fever due to documented fungal infection
- Hepatic dysfunction
- Kidney abnormalities
- Patients who are not eligible for the study participation based on warnings,
precautions and contra medications in the package insert of the study drug at the
investigator's discretion
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Retrospective
Outcome Measure:
Success rate of itraconazole treatment when used for more than 7 days
Outcome Description:
Treatment success is achieved when neutropenia is resolved, ie, when the blood cells count is within the normal reference range.
Outcome Time Frame:
From 7 days to approximately 2 weeks
Safety Issue:
No
Principal Investigator
Janssen Korea, Ltd., Korea Clinical Trial
Investigator Role:
Study Director
Investigator Affiliation:
Janssen Korea, Ltd., Korea
Authority:
Korea: Food and Drug Administration
Study ID:
CR017839
NCT ID:
NCT01706562
Start Date:
May 2011
Completion Date:
September 2011
Related Keywords:
- Neutropenia
- Neutropenia
- Hematologic malignancy
- Itraconazole
- Fungal infection
- Antifungal agent
- Neutropenic fever
- Neutropenia
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