A Study of Empirical Antifungal Therapy With Itraconazole

Neutropenia Clinical Trial

Official title:

Retrospective Observation of Empirical Antifungal Therapy With Itraconazole

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01706562
• Other study ID #: CR017839
• Secondary ID: ITRFUN4055ITR-KO
• Status: Completed
• Phase: Phase 4
• First received: October 11, 2012
• Last updated: February 18, 2013
• Start date: May 2011
• Est. completion date: September 2011

Study information

• Verified date: February 2013
• Source: Janssen Korea, Ltd., Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Description:

This is a retrospective study ie, a study that looks backward in time, usually using medical records and interviews with patients who are already known to have a disease, in patients with itraconazole intravenous prescription as an empirical (based on practical experience) antifungal agent. This study collects baseline information about underlying disease, sign of fungal infection, neutropenia (a decrease in white blood cells), neutropenic fever duration and the reason for discontinuation. Neutropenia is defined as a neutrophil (white blood cell) count of ≤500 cells/mm3 or a count of ≤1000 cells/mm3 with a predicted decrease to ≤500 cells/mm3. Fever is defined as a body temperature ≥38.3 Celsius degrees at least once a day with no definite external factor or a body temperature of ≥38 Celsius degrees continued for at least 1 hour.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Neutropenia

Intervention

Drug:
• Itraconazole
Itraconazole intravenous (IV) 200 mg twice daily for 2 days, a total of 4 doses and then 200 mg once daily until clinically significant resolution of neutropenia.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Korea, Ltd., Korea

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate of itraconazole treatment when used for more than 7 days	Treatment success is achieved when neutropenia is resolved, ie, when the blood cells count is within the normal reference range.	From 7 days to approximately 2 weeks	No
Secondary	Success rate of itraconazole treatment until neutropenia is resolved	Treatment success is achieved when neutropenia is resolved, ie, when the blood cells count is within the normal reference range.	Approximately 2 weeks	No
Secondary	Drop out rate due to the lack of efficacy of itraconazole treatment		Approximately 2 weeks	No