UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005163 |
|---|---|
| Receipt number | R000006132 |
| Scientific Title | Empirical treatment of liposomal amphotericin B for febrile neutropenia. that persists despite broad-spectrum antibacterial therapy |
| Date of disclosure of the study information | 2011/03/01 |
| Last modified on | 2011/03/01 17:59:08 |
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Basic information
Public title
Empirical treatment of liposomal amphotericin B for febrile neutropenia. that persists despite broad-spectrum antibacterial therapy
Acronym
Empiric L-AMB treatment for FN
Scientific Title
Empirical treatment of liposomal amphotericin B for febrile neutropenia. that persists despite broad-spectrum antibacterial therapy
Scientific Title:Acronym
Empiric L-AMB treatment for FN
Region
| Japan |
Condition
Condition
febrile neutropenia
Classification by specialty
| Hematology and clinical oncology | Infectious disease |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the effectiveness of empirical therapy of L-AMB for febrile neutropenia in patients with haematological malignancies.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Successful treatment of any baseline fungal infection, absence of any breakthrough fungal infection during therapy or within seven days after the completion of therapy, survival for seven days after the completion of therapy, no premature discontinuation of study therapy because of drug-related toxicity or lack of efficacy, and resolution of fever during neutropenia.
Key secondary outcomes
Evaluation of the validity of the criteria.
To clarify the relationship between blood concentration of L-AMB and effectiveness or toxicity.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Empirical therapy of L-AMB
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with haematological malignancies accompanied by febrile neutropenia who do not respond to antibiotics after 3~5 days.
Patients who cannot expect recovery of the neutrophile immediately.
Key exclusion criteria
(1) Allergy to L-AMB
(2) Renal failure
(3) Allergy to soy bean
(4) Patients with WBC transfusion
(5) Those considered inappropriate to be participated
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromichi Iwasaki |
Organization
University of Fukui
Division name
The first department of internal medicine
Zip code
Address
23-3 Matsuoka-Shimoaizuki, Eiheiji, Fukui
TEL
0776-61-3111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Ikegaya |
Organization
University of Fukui
Division name
The first department of internal medicine
Zip code
Address
23-3 Matsuoka-Shimoaizuki, Eiheiji, Fukui
TEL
0776-61-3111
Homepage URL
sikegaya@u-fukui.ac.jp
Sponsor or person
Institute
The first department of internal medicine, University of Fukui
Institute
Department
Personal name
Funding Source
Organization
none
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 | 03 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 01 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | 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 | 03 | Month | 01 | Day |
Last modified on
| 2011 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006132
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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