Clinical Trial: A Study of Empirical Antifungal Therapy With Itraconazole

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Retrospective Observation of Empirical Antifungal Therapy With Itraconazole

Brief 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.

Detailed Summary: 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.
Sponsor: Janssen Korea, Ltd., Korea

Current Primary Outcome: Success rate of itraconazole treatment when used for more than 7 days [ Time Frame: From 7 days to approximately 2 weeks ]

Treatment success is achieved when neutropenia is resolved, ie, when the blood cells count is within the normal reference range.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Success rate of itraconazole treatment until neutropenia is resolved [ Time Frame: Approximately 2 weeks ]
    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 ]


Original Secondary Outcome: Same as current

Information By: Janssen Korea, Ltd., Korea

Dates:
Date Received: October 11, 2012
Date Started: May 2011
Date Completion:
Last Updated: February 18, 2013
Last Verified: February 2013