UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000462 |
|---|---|
| Receipt number | R000000547 |
| Scientific Title | Validation study VI of febrile neutropenia guideline 2004 |
| Date of disclosure of the study information | 2006/08/04 |
| Last modified on | 2010/08/04 15:19:02 |
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Basic information
Public title
Validation study VI of febrile neutropenia guideline 2004
Acronym
Treatment for FN in high-risk patients
Scientific Title
Validation study VI of febrile neutropenia guideline 2004
Scientific Title:Acronym
Treatment for FN in high-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
To determine non-inferiority of meropenem, imipenem/cilastatin and cefozopran against effects of cefepime as an initial treatment for the patients with solid tumor and hematologic disorders complicated with neutropenic fever.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Treatment efficacy for 7-day period after antimicrobiral therapy
Key secondary outcomes
Efficacy at day 3-5, 14, 30
Safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
CFPM 2g, 3h-div, q12h
Interventions/Control_2
MEPM 1g, 3h-div, q12h
Interventions/Control_3
IPM/CS 1g, 3h-div, q12h
Interventions/Control_4
CZOP 2g, 3h-div, q12h
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.Hematologic disease or solid tumor (exclusion of low-risk patients)
2.Absolute neutrophil count of less than 1000/micro L
3.Axillary temperature greater than 37.5
4.The patients who have possible infections precess
Key exclusion criteria
1.Isolation of microorgaism resistant to the study drug
2.Serious cardiac, liver or renal dysfunction
3.Past history of allergy to beta-lactum
4.Allergic diathesis
5.Positive skin reaction to study drug if it has to be done by each institution's regulation
6.Elderly patients who can not be evaluated for efficacy
7.Pregnant or lactating woman
8.Age of 15 years or younger
9.Antimicrobial treatment within 3 months prior to the study entry
10.Allogenic hematopoietic stem cell transplantation and older person
11.Patients to exclude from the study by primary physician's decision
Target sample size
400
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
7-45-1, Nanakuma, Jonan-ku, Fukuoka
TEL
092-801-1011
Homepage URL
http://www.fn4th.com/
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
大阪市立大学病院（大阪府）、和歌山県立医科大学病院（和歌山県）日本赤十字社医療センター（東京都）、国立病院機構四国がんセンター（愛媛県）、島根大学医学部附属病院（島根県）、金沢医科大学病院（石川県）、福岡大学病院（福岡県）、近畿大学医学部附属病院（大阪府）、熊本大学医学部附属病院（熊本県）、帝京大学医学部付属病院（東京都）、上ヶ原病院（兵庫県）、市立泉佐野病院（大阪府）、東京医科大学病院（東京都）、兵庫医科大学病院（兵庫県）、大阪医科大学附属病院（大阪府）、岐阜大学医学部附属病院（岐阜県）、NTT関東病院（東京都）、愛媛大学医学部附属病院（愛媛県）、東京都立墨東病院（東京都）、札幌医科大学病院（北海道）、医療法人同心会古賀総合病院（宮崎県）、わかこうかい病院（大阪府）、松下記念病院（大阪府）、金田病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2006 | 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
| 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 | 08 | Month | 04 | 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=R000000547
