The Relationship of Defeverscence and Itraconazole Plasma Level Study in Immunocompromised Participants

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this observational study is to investigate whether a sufficient concentration of itraconazole can influence disappearance of a fever (defeverscence) when intravenous (into the vein) itraconazole is administered for resolving unknown neutropenic fever of participants who are given itraconazole oral solution as a prophylaxis under general treatment conditions.

• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Immunocompromised participants with neutropenic fever who have been treated with itraconazole oral solution as prophylaxis

• Female participants who are postmenopausal or received contraceptive operation or refrain from sexual relations and women of childbearing potential should conduct an effective method of birth control (oral contraceptives, injections, intrauterine device, double barrier method, contraceptive patch and male partner's sterilization) before participation and during the study

• Male participants who will not have a baby within 2 months after the completion of itraconazole therapy

Exclusion Criteria:

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

• Participants with kidney function related abnormalities with calculated creatinine clearance of 30 milliliter per minute (mL/min) or lower

• Aminotransferase level 5 times or higher of normal limit and total bilirubin level 5 milliliter per deciliter (mL/dL) or higher due to hepatic dysfunction

• Participants with dementia (mental decline) related to head injury and hypoxic brain injury

• Participants with mental illness which may interfere with cooperation in treatment and monitoring condition of the clinical study