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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


Phase 4
20 Years
N/A
Not Enrolling
Both
Hematological Malignancies, Neutropenia, Fever

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Trial Information

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.


Inclusion Criteria:



- Immunocompromised patients with neutropenic fever who have been treated with
itraconazole oral solution as prophylaxis

- Female patients who are postmenopausal or received contraceptive operation or refrain
from sexual relations. 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 patients 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

- Patients with kidney function abnormalities with calculated creatinine clearance of
30mL/min or lower

- Aminotransferase level > 5 X Upper Limit of Normal and total bilirubin level > 5
mL/dL due to hepatic dysfunction

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Blood sample to examine the itraconazole trough level (the lowest level of a medicine that is present in the body)

Outcome Time Frame:

Prior to 1st and 7th administration of itraconazole injection

Safety Issue:

No

Principal Investigator

Janssen Korea, Ltd. Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Janssen Korea, Ltd.

Authority:

Korea: Food and Drug Administration

Study ID:

CR016597

NCT ID:

NCT01021683

Start Date:

July 2009

Completion Date:

July 2010

Related Keywords:

  • Hematological Malignancies
  • Neutropenia
  • Fever
  • Itraconazole trough plasma level
  • Antifungal prophylaxis
  • Defeverscence rate
  • Sporanox
  • Neoplasms
  • Neutropenia
  • Hematologic Neoplasms

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