A Study of Empirical Antifungal Therapy With Itraconazole

NCT01706562 | Completed

• 3 other identifiers: CR017839ITRFUN4055ITR-KOR-5088
• Study Type: observational
• Target: 138
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neutropenia

Keywords

Neutropenia; Hematologic malignancy; Itraconazole; Fungal infection; Antifungal agent; Neutropenic fever

Outcome Measures

Primary Outcomes (1)

• Success rate of itraconazole treatment when used for more than 7 days

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

  From 7 days to approximately 2 weeks

Secondary Outcomes (2)

• Success rate of itraconazole treatment until neutropenia is resolved

  Approximately 2 weeks

• Drop out rate due to the lack of efficacy of itraconazole treatment

  Approximately 2 weeks

Study Arms (1)

Itraconazole

Drug: Itraconazole

Interventions

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.

Itraconazole

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Korea, Ltd., Korea: lead

MeSH Terms

Conditions

Neutropenia; Hematologic Neoplasms; Mycoses; Febrile Neutropenia

Interventions

Itraconazole

Condition Hierarchy (Ancestors)

Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders; Neoplasms by Site; Neoplasms; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Janssen Korea, Ltd., Korea Clinical Trial

  Janssen Korea, Ltd., Korea

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2012
• First Posted: October 15, 2012
• Study Start: May 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: February 20, 2013

Record last verified: 2013-02