UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Liposomal amphotericin B(L-AMB) versus Micafungin(MCFG) for empirical therapy in patients of hematological disease with febrile neutropenia (FN) and persistent fever
Title of the study (Brief title)	L-AMB versus MCFG in patients with FN
Region	Japan

Condition
Condition	Febrile neutropenia with persistent fever in patients with hematological disease
Classification by specialty	Medicine in general Hematology and clinical oncology Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	A comparison between Liposomal amphotericin and Micafungin for empirical antifungal therapy in patients with neutropenia and persistent fever
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Efficacy assessed by 1) Successful treatment of any baseline fungal infection, 2) Absence of any breakthrough fungal infection during therapy or within seven days after the completion of therapy, 3) Survival for seven days after the completion of therapy, 4) No premature discontinuation of study therapy because of lack of efficacy or drug-related toxicity and 5) Resolution of fever (defined as a temperature below 38 degrees C for at least 48 hours) during neutropenia
Key secondary outcomes	Safety assessed by 1) Discontinuation of therapy because of lack of efficacy or drug-related toxicity and 2) Incidence of drug-related adverse events

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Liposomal amphotericin B 2.5mg/kg div once a day
Interventions/Control_2	Micafungin 150mg div once a day
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients aged >= 16 years were eligible to participate if they had an absolute neutrophil count < 500/ uL for >=96 hours and fever (>=38 degrees C) within 24 hours before antifungal treatment in spite of antibacterial therapy for >=72 hours. 2) after obtaining signed informed consent.
Key exclusion criteria	1) AST/ALT/total bilirubin > 5 times the upper limit of normal(at each institution). 2) Creatinine clearance <= 30ml/min or serum creatinine >=2mg/dl. 3) History of allergy or hypersensitivity to L-AMB or MCFG. 4) Pregnancy or lactation. 5) Patients who are regarded as inadequate subjects by physician in charge.
Target sample size	140

Research contact person
Name of lead principal investigator	Yoji Ishida
Organization	Iwate Medical University
Division name	Hematology/Oncology
Address	Uchimaru 19-1, Morioka, Japan
TEL	+81-19-651-5111
Email	yishida@iwate-med.ac.jp

Public contact
Name of contact person	Tatsuo Oyake
Organization	Iwate Medical University
Division name	Hematology/Oncology
Address	Uchimaru 19-1, Morioka, Japan
TEL	+81-19-651-5111
Homepage URL
Email	toyake@iwate-med.ac.jp

Sponsor
Institute	Iwate Medical University
Institute
Department

Funding Source
Organization	Iwate Medical University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2011 Year 08 Month 04 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 06 Month 02 Day
Anticipated trial start date	2011 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 08 Month 04 Day
Last modified on	2017 Year 07 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007223