Multi-centre Prospective Randomized Trial Intravenous Itraconazole versus Liposomal Amphotericin B For Empirical Antifungal Therapy In Patients With Persistent fever And Neutropenia (ILEAN study)
- Conditions
- Patients With Persistent fever And Neutropenia
- Registration Number
- JPRN-UMIN000005529
- Lead Sponsor
- ational Hospital Organization
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 850
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method