Observational Study Investigating the Response Rate of Itraconazole Injection in Treating Immunocompromised Patients

May 14, 2014 updated by: Janssen Korea, Ltd., Korea

Efficacy According to Treatment Timing in Immunocompromised Patients Treated With Itraconazole Injection as an Empiric Antifungal Therapy

The purpose of this observational study is to examine the rate at which elevated body temperature (fever) is relieved by an itraconazole injection administrated to patients experiencing neutropenic fever . A neutropenic fever is an elevated body temperature that occurs at a time when the patient's white blood cell count is low. White blood cells aid the body's normal defenses against infection, so a fever during this period might make it difficult for the patient to fight infections.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is a multi-center, open-label, prospective and observational study enrolling approximately 440 patients. The primary objective of this study is to examine the fever response rate after itraconazole IV (directly into the vein) is administered for more than 3 days to patients with neutropenic fever based on investigator's discretion. Follow-up will be performed before and after administration and for 7 days after administration. Study population consists of the patients who visit a study center during the study period and are judged to have neutropenic fever associated with hematologic malignancy such as acute leukemia, hodgkin's lymphoma, non-hodgkin's lymphoma, myelodysplastic syndrome, and multiple myeloma. The decision to treat patients with itraconazole is as per physician discretion and doses are determined based upon approved labeling recommendations and physician discretion. The safety and efficacy of itraconazole administered beyond 29 days is not yet been established in the treatment of fever in neutropenic patients suspected of systemic fungal infection. Itraconazole 200 mg IV twice daily for 2 days, for a total of 4 doses, then 200 mg IV once daily for 12 days. After the administration for a total of 14 days, itraconazole oral solution 200 mg (20 ml) twice daily should be continued for a total of 14 days

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
438

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Study population consists of the patients who visit a study center during the study period and are judged to have neutropenic fever associated with hematologic malignancy such as acute leukemia, hodgkin's lymphoma, non-hodgkin's lymphoma, myelodysplastic syndrome, and multiple myeloma

Description

Inclusion Criteria:

  • Patients with neutropenic fever who receive antineoplastic therapy or stem cell transplantation for acute leukemia, hodgkin's lymphoma, non-hodgkin's lymphoma, myelodysplastic syndrome, and multiple myeloma
  • Patients who are recommended to receive itraconazole injection for treatment of acute leukemia, hodgkin's lymphoma, non-hodgkin's lymphoma, myelodysplastic syndrome, and multiple myeloma

Exclusion Criteria:

  • Childbearing women who are pregnant or likely to be pregnant during the study period and male patients who are neither infertile nor willing to refrain from sexual relations but whose partner does not conduct an effective contraception (implant, injections, oral contraceptives, intrauterine device, etc.)
  • Fever due to documented deep-seated fungal infection at the entry into the study (documented candidemia will be included)
  • Significant hepatic and renal dysfunction
  • Patients who, at the discretion of the investigator, are not eligible for the study participation based on warnings, precautions and contraindicated medications as listed in the package insert of the drug

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
001
Pts. w/ neutropenic fever associated w/ hematologic malignancy Itraconazole 200 mg twice daily for 2 days for a total of 4 doses then 200 mg once daily for 12 days. After 14 days of IV administration itraconazole oral solution 200 mg twice daily should be continued for a total of 14 days until clinically significant resolution of neutropenia resolves
Drug: Pts. w/ neutropenic fever associated w/ hematologic malignancy
Itraconazole 200 mg twice daily for 2 days for a total of 4 doses, then 200 mg once daily for 12 days. After 14 days of IV administration, itraconazole oral solution 200 mg twice daily should be continued for a total of 14 days until clinically significant resolution of neutropenia resolves

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Frequency rate at which fever is resolved and the time to fever resolution
Time Frame: after completion of the treatment of 3 to 14 days and after 7 days of follow up period
after completion of the treatment of 3 to 14 days and after 7 days of follow up period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Defervescence rate according to baseline result of Chest X-ray, CT (Computed tomography, a medical imaging method), Galactomannan test (diagnosis test for fungal infection)
Time Frame: after completion of 3 to 14 days of treatment and after 7 days of follow up period
after completion of 3 to 14 days of treatment and after 7 days of follow up period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Korea, Ltd., Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 21, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 2, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 15, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR015691

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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