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| ID | Type | Description | Link |
|---|---|---|---|
| ITRFUN4055 | Other Identifier | Janssen Korea, Ltd., Korea | |
| ITR-KOR-5088 | Other Identifier | Janssen Korea, Ltd., Korea |
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The purpose of this study is to investigate the overall success rate of itraconazole intravenous treatment for a period of more than 7 days.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Itraconazole |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Success rate of itraconazole treatment until neutropenia is resolved | Treatment success is achieved when neutropenia is resolved, ie, when the blood cells count is within the normal reference range. | Approximately 2 weeks |
| Drop out rate due to the lack of efficacy of itraconazole treatment |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Korea, Ltd., Korea Clinical Trial | Janssen Korea, Ltd., Korea | Study Director |
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| ID | Term |
|---|---|
| D009503 | Neutropenia |
| D019337 | Hematologic Neoplasms |
| D009181 | Mycoses |
| D064147 | Febrile Neutropenia |
| ID | Term |
|---|---|
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Approximately 2 weeks |
| D006425 |
| Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D010879 |
| Piperazines |