Clinical trial NCT01706562: A Study of Empirical Antifungal Therapy With Itraconazole
Official title: Retrospective Observation of Empirical Antifungal Therapy With Itraconazole
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neutropenia
Keywords: Neutropenia
Hematologic malignancy
Itraconazole
Fungal infection
Antifungal agent
Neutropenic fever
Lead sponsor: Janssen Korea, Ltd., Korea
Sponsor class: INDUSTRY
First posted: 2012-10-15
Enrollment: 138
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population consists of patients with hematologic malignancy who visited a study center and were treated with itraconazole intravenous (IV) for more than 7 days.

Brief summary: The purpose of this study is to investigate the overall success rate of itraconazole intravenous treatment for a period of more than 7 days.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Success rate of itraconazole treatment when used for more than 7 days
timeFrame: From 7 days to approximately 2 weeks
Secondary outcomes:
measure: Success rate of itraconazole treatment until neutropenia is resolved
timeFrame: Approximately 2 weeks
measure: Drop out rate due to the lack of efficacy of itraconazole treatment
timeFrame: Approximately 2 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Janssen Korea, Ltd., Korea
name: Janssen Korea, Ltd., Korea Clinical Trial
role: STUDY_DIRECTOR
References: