A Study of Empirical Antifungal Therapy With Itraconazole

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Korea, Ltd., Korea
• Treatments: Antifungal Agents; Hydroxyitraconazole; Itraconazole; Miconazole

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