The Relationship of Defeverscence and Itraconazole Plasma Level Using Itraconazole IV as an Empiric Therapy in Immunocompromised Patients Who Had Previously Been Treated With Itraconazole Oral Solution as Prophylaxis
This is a prospective, open-label, multicenter, and observational study executed in 20
organizations nationwide with around 250 patients, in order to examine the correlation
between a sufficient blood concentration of itraconazole and disappearance of a fever
(defeverscence) when a itraconazole injection is administered for resolving unknown
neutropenic fever of patients who are given itraconazole oral solution as a prophylaxis
under general treatment conditions. It is recommended that the IV form of the drug be
administered 200 mg twice daily for 2 days, a total of 4 doses and then 200 mg once daily
for 12 days. After the administration for a total of 14 days, itraconazole oral solution 200
mg (20 ml) twice daily should be continued for a total of 14 days until clinically
significant resolution of neutropenia resolves.
Observational
Observational Model: Case-Only, Time Perspective: Prospective
Blood sample to examine the itraconazole trough level (the lowest level of a medicine that is present in the body)
Prior to 1st and 7th administration of itraconazole injection
No
Janssen Korea, Ltd. Clinical Trial
Study Director
Janssen Korea, Ltd.
Korea: Food and Drug Administration
CR016597
NCT01021683
July 2009
July 2010
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