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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005015
Receipt No. R000005965
Scientific Title A study on the efficacy of anti-influenza drugs, intravenous peramivir against influenza virus infections.
Date of disclosure of the study information 2011/02/03
Last modified on 2015/09/29

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Basic information
Public title A study on the efficacy of anti-influenza drugs, intravenous peramivir against influenza virus infections.
Acronym The efficacy of anti-influenza drugs, intravenous peramivir against influenza virus infections: an open-label, multi-centre study.
Scientific Title A study on the efficacy of anti-influenza drugs, intravenous peramivir against influenza virus infections.
Scientific Title:Acronym The efficacy of anti-influenza drugs, intravenous peramivir against influenza virus infections: an open-label, multi-centre study.
Region
Japan

Condition
Condition Influenza virus infection
Classification by specialty
Medicine in general Gastroenterology Pneumology
Infectious disease Emergency medicine Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of intravenous peramivir in patients who are inhaling of oxygen, diabetes, renal insufficiency or treating in ICU with influenza virus infections.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The improvement in clinical status ( improvement ratio )
Key secondary outcomes The time to alleviation of influenza symptoms.
Incidence of influenza-related complications.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients or guardian of the patients with informed consent.
2) Age: more than 16 years ( at the time the informed consent form is signed )
3) Gender: Male or female
4) Patients with influenza A and/or B diagnosed with a nasal or throat swab specimen by RAT ( rapid antigen test ) etc.
5) Patients of the following any criteria( at the time the informed consent form is signed ): Inhaling of oxygen, Progressing diabetes, Renal insufficiency, Treating in ICU
Key exclusion criteria 1) Patients with convulsions or other neurological symptoms ( consciousness disorder, abnormal behavior/speech ) within the past 2 years.
2) History of hypersensitivity, allergy or serious adverse drug event caused by oseltamivir phosphate ( Tamiflu ), zanamivir hydrate ( Relenza ) or peramivir hydrate ( Rapiacta ).
3) Women who are pregnant or suspected to be pregnant and women who are breast-feeding.
4) Any other patients whose condition is inappropriate for the evaluation of this clinical study as judged by the investigator.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuka Yamagishi
Organization Aichi Medical University Hospital
Division name Department of Clinical Infectious Diseases
Zip code
Address 1-1 Yazakokarimata,Nagakute,Aichi,480-1195, Japan
TEL 0561-62-3311
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Aichi Medical University Hospital
Division name Department of Clinical Infectious Diseases
Zip code
Address 1-1 Yazakokarimata,Nagakute,Aichi,480-1195, Japan
TEL 0561-62-3311
Homepage URL
Email

Sponsor
Institute Department of Clinical Infectious Diseases, Aichi Medical University Hospital
Institute
Department

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
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 愛知医科大学病院(愛知県),愛知医科大学メディカルクリニック(愛知県),医療法人 育寿会 MIWA内科胃腸科CLINIC(岐阜県),六条わたなべ内科(岐阜県),松原耳鼻いんこう科医院(岐阜県),近藤ゆか耳鼻咽喉科(岐阜県),いずみレディスクリニック(岐阜県),名古屋セントラル病院(愛知県),津山中央病院(岡山県),岐阜大学医学部附属病院(岐阜県),大同病院(愛知県),多治見市民病院(岐阜県),海南病院(愛知県),名古屋記念病院(愛知県)

Other administrative information
Date of disclosure of the study information
2011 Year 02 Month 03 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
2011 Year 01 Month 18 Day
Date of IRB
Anticipated trial start date
2011 Year 02 Month 01 Day
Last follow-up date
2012 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observation about items below will be investigated (required items).
heart rate
respiratory rate
clinical symptoms (fervescence, headache, muscular or joint pain, feverish or chill, fatigue, cough, sore throat, nasal obstruction)

Management information
Registered date
2011 Year 02 Month 03 Day
Last modified on
2015 Year 09 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005965

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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