Know Cancer

forgot password

Retrospective Observation of Empirical Antifungal Therapy With Itraconazole

Phase 4
20 Years
Not Enrolling

Thank you

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:


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:


Principal Investigator

Janssen Korea, Ltd., Korea Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Janssen Korea, Ltd., Korea


Korea: Food and Drug Administration

Study ID:




Start Date:

May 2011

Completion Date:

September 2011

Related Keywords:

  • Neutropenia
  • Neutropenia
  • Hematologic malignancy
  • Itraconazole
  • Fungal infection
  • Antifungal agent
  • Neutropenic fever
  • Neutropenia