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A Study of Empirical Antifungal Therapy With Itraconazole

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier:
NCT01706562
First received: October 11, 2012
Last updated: February 18, 2013
Last verified: February 2013
History of Changes
  Purpose

The purpose of this study is to investigate the overall success rate of itraconazole intravenous treatment for a period of more than 7 days.


Condition Intervention Phase
Neutropenia
 Drug: Itraconazole
 Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Observation of Empirical Antifungal Therapy With Itraconazole

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Janssen Korea, Ltd., Korea:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 138
Study Start Date: May 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Itraconazole 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.

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01706562

Sponsors and Collaborators
Janssen Korea, Ltd., Korea
Investigators
Study Director: Janssen Korea, Ltd., Korea Clinical Trial Janssen Korea, Ltd., Korea
  More Information

No publications provided

Responsible Party: Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier: NCT01706562     History of Changes
Other Study ID Numbers: CR017839, ITRFUN4055, ITR-KOR-5088
Study First Received: October 11, 2012
Last Updated: February 18, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Janssen Korea, Ltd., Korea:
Neutropenia
Hematologic malignancy
Itraconazole
 Fungal infection
Antifungal agent
Neutropenic fever

Additional relevant MeSH terms:
Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Antifungal Agents
Clotrimazole
Miconazole
Itraconazole
 Hydroxyitraconazole
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Local
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013