UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000396 |
|---|---|
| Receipt number | R000000354 |
| Scientific Title | Validation study of new febrile neutropenia guideline-Comparative study between oral levofloxacin and parenteral cefepime in low-risk patients with febrile neutropenia |
| Date of disclosure of the study information | 2006/04/04 |
| Last modified on | 2010/08/04 15:17:56 |
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Basic information
Public title
Validation study of new febrile neutropenia guideline-Comparative study between oral levofloxacin and parenteral cefepime in low-risk patients with febrile neutropenia
Acronym
Treatment for FN in Low-Risk patients
Scientific Title
Validation study of new febrile neutropenia guideline-Comparative study between oral levofloxacin and parenteral cefepime in low-risk patients with febrile neutropenia
Scientific Title:Acronym
Treatment for FN in Low-Risk patients
Region
| Japan |
Condition
Condition
Febrile neutropenia
Classification by specialty
| Medicine in general | Hematology and clinical oncology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Antibacterial effect for low-risk febrile neutropenia patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Treatment efficacy at 7 days after antimicrobiral therapy
Key secondary outcomes
Adverse events, treatment results in 3-5 days after the start of therapy, succes rate as an outpatient, survival, antibacterial effect
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
CFPM 4g,1h-div, q12
Interventions/Control_2
LVFX 200mg, tid
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
Solid tumor, multiple myeloma, acute leukemia
Axiillary temperature greater than 38C on one occasion or greater than 37.5C lasting for more than 1 hour
Absolute neutrophil count of less than 500/microL
Low-risk patient
Key exclusion criteria
Poor-risk acute leukemia patients
Isolation of microorganism resistant to the study drugs
Past history of allergy to beta-lactum or study drugs
Pregnant or lactating woman
Age of 15 years or younger
Antimicrobial treatment within 3 months prior to the study entry
Allegenic hematopoietic stem cell transplantation
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihisa Kanamaru |
Organization
Kinki University
Division name
Department of Hematology
Zip code
Address
377-2 Ohno-Higashi, Osaka-Sayama, Osaka
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuo Tamura |
Organization
Fukuoka University
Division name
Depatment of Internal Medicine
Zip code
Address
TEL
Homepage URL
http://www.fn4th.com/
ktamura@fukuoka-u.ac.jp
Sponsor or person
Institute
Japan Febrile Neutropenia Study Group
Institute
Department
Personal name
Funding Source
Organization
Japan Febrile Neutropenia Study Group
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
| 2006 | Year | 04 | Month | 04 | Day |
Related information
URL releasing protocol
http://www.fn4th.com/
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
| 2005 | Year | 09 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2006 | Year | 04 | Month | 03 | Day |
Last modified on
| 2010 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000354
