Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pts. w/ neutropenic fever associated w/ hematologic malignancy | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency rate at which fever is resolved and the time to fever resolution | after completion of the treatment of 3 to 14 days and after 7 days of follow up period |
| Measure | Description | 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) | after completion of 3 to 14 days of treatment and after 7 days of follow up period |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Janssen Korea, Ltd. Clinical Trial | Janssen Korea, Ltd. | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24431907 | Derived | Kim SJ, Cheong JW, Min YH, Choi YJ, Lee DG, Lee JH, Yang DH, Lee SM, Kim SH, Kim YS, Kwak JY, Park J, Kim JY, Kim HG, Kim BS, Ryoo HM, Jang JH, Kim MK, Kang HJ, Cho IS, Mun YC, Jo DY, Kim HY, Park BB, Kim JS. Success rate and risk factors for failure of empirical antifungal therapy with itraconazole in patients with hematological malignancies: a multicenter, prospective, open-label, observational study in Korea. J Korean Med Sci. 2014 Jan;29(1):61-8. doi: 10.3346/jkms.2014.29.1.61. Epub 2013 Dec 26. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D009503 | Neutropenia |
| D005334 | Fever |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D007960 | Leukocyte Disorders |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided