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Clinical Trials/JPRN-UMIN000005529
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.

Registry
who.int
Start Date
April 29, 2011
End Date
March 31, 2015
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
ational Hospital Organization

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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