A Study of Empirical Antifungal Therapy With Itraconazole
The purpose of this study is to investigate the overall success rate of itraconazole intravenous treatment for a period of more than 7 days.
|Study Design:||Observational Model: Cohort
Time Perspective: Retrospective
|Official Title:||Retrospective Observation of Empirical Antifungal Therapy With Itraconazole|
- Success rate of itraconazole treatment when used for more than 7 days [ Time Frame: From 7 days to approximately 2 weeks ] [ Designated as safety issue: No ]Treatment success is achieved when neutropenia is resolved, ie, when the blood cells count is within the normal reference range.
- Success rate of itraconazole treatment until neutropenia is resolved [ Time Frame: Approximately 2 weeks ] [ Designated as safety issue: No ]Treatment success is achieved when neutropenia is resolved, ie, when the blood cells count is within the normal reference range.
- Drop out rate due to the lack of efficacy of itraconazole treatment [ Time Frame: Approximately 2 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||May 2011|
|Study Completion Date:||September 2011|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01706562
|Study Director:||Janssen Korea, Ltd., Korea Clinical Trial||Janssen Korea, Ltd., Korea|