An observational study in Neutropenia, sponsored by Janssen Korea, Ltd., Korea. Completed. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2013-02-20.
Sponsored by Janssen Korea, Ltd., Korea · Observational
The purpose of this study is to investigate the overall success rate of itraconazole intravenous treatment for a period of more than 7 days.
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.
396 studies on the registry are indexed under Neutropenia; 57 are open to participants now.
This study's enrollment of 138 is below the median of 175 across 96 observational studies indexed under Neutropenia.
Browse Neutropenia studies →Janssen Korea, Ltd., Korea is the lead sponsor of 75 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Study population consists of patients with hematologic malignancy who visited a study center and were treated with itraconazole intravenous (IV) for more than 7 days.
Exclusion Criteria:
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.
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.
Time frame: From 7 days to approximately 2 weeks
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.
Time frame: Approximately 2 weeks
Drop out rate due to the lack of efficacy of itraconazole treatment
Time frame: Approximately 2 weeks
No study locations are listed for this record.
This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.
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Janssen Korea, Ltd., Korea