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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000396
Receipt No. 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

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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
Email

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/
Email ktamura@fukuoka-u.ac.jp

Sponsor
Institute Japan Febrile Neutropenia Study Group
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000354

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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