A Study of Empirical Antifungal Therapy With Itraconazole

Retrospective Observation of Empirical Antifungal Therapy With Itraconazole

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

Study Overview

• Status: Completed
• Conditions: Neutropenia
• Intervention / Treatment: Drug: Itraconazole

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.

• Study Type: Observational
• Enrollment (Actual): 138

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Itraconazole	Drug: Itraconazole; Itraconazole intravenous (IV) 200 mg twice daily for 2 days, a total of 4 doses and then 200 mg once daily until clinically significant resolution of neutropenia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate of itraconazole treatment when used for more than 7 days	Treatment success is achieved when neutropenia is resolved, ie, when the blood cells count is within the normal reference range.	From 7 days to approximately 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate of itraconazole treatment until neutropenia is resolved	Treatment success is achieved when neutropenia is resolved, ie, when the blood cells count is within the normal reference range.	Approximately 2 weeks
Drop out rate due to the lack of efficacy of itraconazole treatment		Approximately 2 weeks

Collaborators and Investigators

• Sponsor: Janssen Korea, Ltd., Korea

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (ACTUAL): September 1, 2011
• Study Completion (ACTUAL): September 1, 2011

Study Registration Dates

• First Submitted: October 11, 2012
• First Submitted That Met QC Criteria: October 11, 2012
• First Posted (ESTIMATE): October 15, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): February 20, 2013
• Last Update Submitted That Met QC Criteria: February 18, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Itraconazole; Fungal infection; Neutropenia; Hematologic malignancy; Neutropenic fever; Antifungal agent
• Additional Relevant MeSH Terms: Hematologic Diseases; Agranulocytosis; Leukopenia; Leukocyte Disorders; Neutropenia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Itraconazole
• Other Study ID Numbers: CR017839; ITRFUN4055 (OTHER: Janssen Korea, Ltd., Korea); ITR-KOR-5088 (OTHER: Janssen Korea, Ltd., Korea)