NCT01706562

A Study of Empirical Antifungal Therapy With Itraconazole

Retrospective Observation of Empirical Antifungal Therapy With Itraconazole

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 138 (actual)
• Sponsor: Janssen Korea, Ltd., Korea · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Neutropenia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-05-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2012-10-15
• Last updated: 2013-02-20