Patients With Persistent fever And Neutropenia
Conditions
Interventions
Liposomal amphotericin B is initiated and continued at 3mg per kilogram intravenously per day.
Itraconazole is initiated at 200mg intravenously every12hours for 5 times followed by 200mg intravenously
Sponsors
National Hospital Organization
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. ECOG Performance Status of 0 to 3 at initial administration of the study drug. 2. Patients who have been with chemotherapy for less than 30 days for hematological malignancy. 3. Neutropenia (an absolute neutrophil count below 500 cells per cubic millimeter ) persisted for 96 hours. 4. Patients had received more than 96 hours of systemic anti-bacterial therapy while continuing to have fever. After 96 hours, axillary temperature was above 37.5 C at least one time. 5. No prophylactic antifungal therapy without Amphotericin B syrup, micafungin, caspofungin, miconazole oral gel,and antifungal skin cream. (Patients who not received fluconazole within 4 weeks before the initial administration of the study drug) 6. Patients with adequately maintained organ functions (e.g., bone marrow, liver, heart, and kidney funtions). Platelets counts: >5,000 per cubic millimeter ALP: <3.0 times the upper limit of the institutional normal range Total bilirubin: < 3.0 times the upper limit of the institutional normal range AST (GOT): < 5.0 times the upper limit of the institutional normal range ALT (GPT): < 5.0 times the upper limit of the institutional normal range Left ventricular ejection fraction:> 50% Creatinine clearance: >30mL / min 7. Patients capable of personally giving voluntary informed consent in writing to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Patients have been proved invasive fungal disease at initial administration of the study drug 2. Patients have been diagnosed as definite virus or bacterial infection at initial administration of the study drug 3. Patients with prior severe allergies to intravenous itraconazole and liposomal amphotericin B 4. Patients with liver cirrhosis 5. Patients with serious, active heart disease 6. Patients with, or confirmed in the past to have had, angina pectoris, cardiac infarction, congestive heart failure 7. Patients with serious psychological disease 8. Patients who are pregnant or lactating 9. Patients who received pimozide, blonanserin, triazolam, quinidine sulfate, bepridil hydrochloride hydrate, azelnidipine, nisoldipine, simvastatin, ergotamine tartrate, dihydroergotamine mesilate, vardenafil hydrochloride hydrate, sildenafil citrate, eplerenone, aliskiren fumarate, tadalafil, or rivaroxaban 10. Patients who receive donor leukocyte infusion 11. Patients otherwise judged by investigator or sub investigator to be unsuitable 12. Patients who received other investigational products or unapproved medication or Japan clinical oncology group protocol study 13. Patients who are currently receiving or going to receive Vincristine 14. Patients who have proved invasive fungal disease in the past
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall favorable response ( No.1, 2, 3, 4, and 5 key secondary outcomes all succeed) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Response of patients with base-line fungal infections by completion of trial therapy 2. No breakthrough fungal infection 3. No discontinuation due to toxicity before recovery from neutropenia 4. Resolution of fever during neutropenia 5. Survival 7 days after completion of trial therapy 6. Adverse events 7. Probable invasive fungal disease by completion of trial therapy | — |
Countries
Japan
Contacts
Public ContactIsao Yoshida
National Hospital Organization, Shikoku Cancer Center Hematologic oncology
Outcome results
None listed