Completed

Retrospective Observation of Empirical Antifungal Therapy With Itraconazole

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What is being collected

Drug Data

Collected from past medical records and data - Retrospective
Drug
Who is being recruted

Cytopenia+11

+ Agranulocytosis

+ Bacterial Infections and Mycoses

Over 20 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: May 2011
See protocol details

Summary

Principal SponsorJanssen Korea, Ltd., Korea
Last updated: February 20, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2011

Actual date on which the first participant was enrolled.

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.

NCT01706562
Principal SponsorJanssen Korea, Ltd., Korea
Last updated: February 20, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

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

138 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 20 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

CytopeniaAgranulocytosisBacterial Infections and MycosesHematologic DiseasesHemic and Lymphatic DiseasesInfectionsLeukocyte DisordersLeukopeniaNeoplasmsNeoplasms by SiteMycosesNeutropeniaHematologic NeoplasmsFebrile Neutropenia

Criteria

2 inclusion criteria required to participate
Patients who receive itraconazole intravenous (IV) treatment for more than 7 days
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)
5 exclusion criteria prevent from participating
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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CompletedNo study centers