JPRN-UMIN000005529
Completed
Phase 4
Multi-centre Prospective Randomized Trial Intravenous Itraconazole versus Liposomal Amphotericin B For Empirical Antifungal Therapy In Patients With Persistent fever And Neutropenia (ILEAN study) - Intravenous Itraconazole versus Liposomal Amphotericin B For Empirical Antifungal Therapy
ational Hospital Organization0 sites850 target enrollmentApril 29, 2011
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ational Hospital Organization
- Enrollment
- 850
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
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
Outcomes
Primary Outcomes
Not specified
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