UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005015 |
|---|---|
| Receipt number | 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 13:59:55 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
Sponsor or person
Institute
Department of Clinical Infectious Diseases, Aichi Medical University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005965
