UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006114 |
|---|---|
| Receipt number | R000007223 |
| Scientific Title | Liposomal amphotericin B(L-AMB) versus Micafungin(MCFG) for empirical therapy in patients of hematological disease with febrile neutropenia (FN) and persistent fever |
| Date of disclosure of the study information | 2011/08/04 |
| Last modified on | 2017/07/25 21:25:33 |
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Basic information
Public title
Liposomal amphotericin B(L-AMB) versus Micafungin(MCFG) for empirical therapy in patients of hematological disease with febrile neutropenia (FN) and persistent fever
Acronym
L-AMB versus MCFG in patients with FN
Scientific Title
Liposomal amphotericin B(L-AMB) versus Micafungin(MCFG) for empirical therapy in patients of hematological disease with febrile neutropenia (FN) and persistent fever
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Yoji Ishida |
Organization
Iwate Medical University
Division name
Hematology/Oncology
Zip code
Address
Uchimaru 19-1, Morioka, Japan
TEL
+81-19-651-5111
yishida@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuo Oyake |
Organization
Iwate Medical University
Division name
Hematology/Oncology
Zip code
Address
Uchimaru 19-1, Morioka, Japan
TEL
+81-19-651-5111
Homepage URL
toyake@iwate-med.ac.jp
Sponsor or person
Institute
Iwate Medical University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 06 | Month | 02 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007223
