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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000462
Receipt No. 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

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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
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 7-45-1, Nanakuma, Jonan-ku, Fukuoka
TEL 092-801-1011
Homepage URL http://www.fn4th.com/
Email

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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000547

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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