Observational Study Investigating the Response Rate of Itraconazole Injection in Treating Immunocompromised Patients

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this observational study is to examine the rate at which elevated body temperature (fever) is relieved by an itraconazole injection administrated to patients experiencing neutropenic fever . A neutropenic fever is an elevated body temperature that occurs at a time when the patient's white blood cell count is low. White blood cells aid the body's normal defenses against infection, so a fever during this period might make it difficult for the patient to fight infections.

• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Patients with neutropenic fever who receive antineoplastic therapy or stem cell transplantation for acute leukemia, hodgkin's lymphoma, non-hodgkin's lymphoma, myelodysplastic syndrome, and multiple myeloma

• Patients who are recommended to receive itraconazole injection for treatment of acute leukemia, hodgkin's lymphoma, non-hodgkin's lymphoma, myelodysplastic syndrome, and multiple myeloma

Exclusion Criteria:

• Childbearing women who are pregnant or likely to be pregnant during the study period and male patients who are neither infertile nor willing to refrain from sexual relations but whose partner does not conduct an effective contraception (implant, injections, oral contraceptives, intrauterine device, etc.)

• Fever due to documented deep-seated fungal infection at the entry into the study (documented candidemia will be included)

• Significant hepatic and renal dysfunction

• Patients who, at the discretion of the investigator, are not eligible for the study participation based on warnings, precautions and contraindicated medications as listed in the package insert of the drug