Observational Study Investigating the Response Rate of Itraconazole Injection in Treating Immunocompromised Patients
Summary
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.
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 Design
Observational Model: Case-Only, Time Perspective: Prospective
Conditions
Hematological Malignancies
Intervention
Pts. w/ neutropenic fever associated w/ hematologic malignancy
Status
Completed
Source
Janssen Korea, Ltd., Korea
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01060462
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:16:14-0400
Clinical Trials
Assessment of sTREM-1 as a Diagnostic Marker in Patients With Neutropenic Fever
The soluble triggering receptor expressed on myeloid cells-1 (sTREM-1) was an established biomarker useful for infection in non-neutropenic patients. In this study, we tested sTREM-1 in th...
Early Application of CPAP in Hematologic
The purpose of this study is to evaluate the use of CPAP in the prevention of acute respiratory failure in neutropenic ( or hematologic malignancy ) patients .CPAP applied preventively in ...
A Phase 1 Study of MKC-1 in Patients With Refractory Hematologic Malignancies
The main objectives of this study are to evaluate the side effects of MKC-1 and to determine a safe dose of MKC-1 for future studies in patients with hematological malignancies
To compare the safety and efficacy of piperacillin/tazobactam (4 g/500 mg) administered intravenously every 6 hours to cefepime (2 g) administered intravenously every 8 hours for the empir...
The purpose of this study is to investigate the hypothesis that the efficacy of intravenous (IV) itraconazole followed by oral itraconazole is non-inferior to that of intravenous caspofung...
PubMed Articles
The Critical Role of Inflammation in the Pathogenesis and Progression of Myeloid Malignancies.
Hematopoietic stem cells (HSCs) maintain an organism's immune system for a lifetime, and derangements in HSC proliferation and differentiation result in hematologic malignancies. Chronic inflammation ...
Mediastinal germ cell tumor (MGCT), which accounts for 1% to 3% of extragonadal germ cell tumors, has unique manifestations; it is associated with several types of hematologic malignancy, particularly...
Novel Immunotherapies for T Cell Lymphoma and Leukemia.
Novel immunotherapies such as checkpoint inhibitors, bispecific antibodies, and chimeric antigen receptor T cells are leading to promising responses when treating solid tumors and hematological malign...
Febrile neutropenia may be a sign of severe infection, and is associated with significant morbidity and mortality in high-risk patients with hematologic malignancies. Extended infusion of β-lactam an...
Predictors of outcome in patients with hematologic malignancies admitted to the intensive care unit.
Several studies showed conflicting results about prognosis and predictors of outcome of critically ill patients with hematological malignancies (HM). The aim of this study is to determine the hospital...
Medical and Biotech [MESH] Definitions
Lomustine
An alkylating agent of value against both hematologic malignancies and solid tumors.
Pregnancy Complications, Hematologic
The co-occurrence of pregnancy and a blood disease (HEMATOLOGIC DISEASES) which involves BLOOD CELLS or COAGULATION FACTORS. The hematologic disease may precede or follow FERTILIZATION and it may or may not have a deleterious effect on the pregnant woman or FETUS.
Enterocolitis, Neutropenic
A syndrome characterized by inflammation in the ILEUM, the CECUM, and the ASCENDING COLON. It is observed in cancer patients with CHEMOTHERAPY-induced NEUTROPENIA or in other immunocompromised individuals (IMMUNOCOMPROMISED HOST).
Trench Fever
An intermittent fever characterized by intervals of chills, fever, and splenomegaly each of which may last as long as 40 hours. It is caused by BARTONELLA QUINTANA and transmitted by the human louse.
Hirudin Therapy
Use of HIRUDINS as an anticoagulant in the treatment of cardiological and hematological disorders.
