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Completed

NCT Number: NCT01706562

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Itraconazole

Drug

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Drop out rate due to the lack of efficacy of itraconazole treatment

    Time frame: Approximately 2 weeks

Sponsors and collaborators

Lead sponsor

Janssen Korea, Ltd., Korea

Industry

Registry information

Official study title

Retrospective Observation of Empirical Antifungal Therapy With Itraconazole

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Oct 15, 2012
Registry last updated
Feb 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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