UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009479 |
|---|---|
| Receipt number | R000011137 |
| Scientific Title | A multicenter, randomized controlled study of the clinical efficacy of intravenous peramivir versus oseltamivir against influenza A and B virus infection in high-risk patients |
| Date of disclosure of the study information | 2012/12/05 |
| Last modified on | 2017/02/24 11:14:24 |
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Basic information
Public title
A multicenter, randomized controlled study of the clinical efficacy of intravenous peramivir versus oseltamivir against influenza A and B virus infection in high-risk patients
Acronym
Comparative study of peramivir and
oseltamivir in the influenza virus
infection
Scientific Title
A multicenter, randomized controlled study of the clinical efficacy of intravenous peramivir versus oseltamivir against influenza A and B virus infection in high-risk patients
Scientific Title:Acronym
Comparative study of peramivir and
oseltamivir in the influenza virus
infection
Region
| Japan |
Condition
Condition
Influenza virus infection
Classification by specialty
| Medicine in general | Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of clinical and viral effects of peramivir compared with oseltamivir in high-risk patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The duration of fever
Key secondary outcomes
Symptoms of influenza infection, viral titer and subtype, complications, exacerbation of underlying diseases, H275Y mutation of the virus isolated from the patients with poor clinical effects,
The detection of colonized pneumococcus in nasal pharynx in the patients complicated secondary bacterial pneumonia
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Peramivir,
Intravenously administration
600mg once a day, allowing daily injection if the patient condition is severe.
Interventions/Control_2
Oseltamivir,
Orally administration, 75mg twice a day for 5 days.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients who satisfied below 1)-7):
1)Age:>=20
2)Agreement with documents
3)Fever>=38.0 degrees centigrade
4)>=2 items of ISS* which as moderate symptoms
5)Within 48hour after onset:
Onset time is defined as below
(1)First time at increase of body temperature (>=1 degrees centigrade as usual)
(2)First time which the patient
aware >=1 items of ISS*
6)Positive for Rapid Antigen Test kit
7)With at least one risk factor
*ISS=Influenza Symptoms Severity
Key exclusion criteria
1)contraindication of peramivir and oseltamivir
2)pregnant or probable pregnant women
3)Inappropriate judged by doctors
4)pneumonia on the 1st day of visiting hospital
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeki Nakamura |
Organization
Nagasaki University Hospital
Division name
Second Department of Internal Medicine
Zip code
Address
1-7-1, Sakamoto, Nagasaki city, Nagasaki prefecture.
TEL
095-819-7273
moju516@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taiga Miyazaki |
Organization
Nagasaki evaluation organization for clinical interventions
Division name
office
Zip code
Address
1-7-1, Sakamoto, Nagasaki city, Nagasaki prefecture.
TEL
095-819-7273
Homepage URL
shinkin@peath.co.jp
Sponsor or person
Institute
Nagasaki evaluation organization for clinical interventions
Institute
Department
Personal name
Funding Source
Organization
Nagasaki evaluation organization for clinical interventions
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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
・長崎大学病院（長崎県）
・日本赤十字社長崎原爆病院（長崎県）
・日本赤十字社長崎原爆諫早病院（長崎県）
・地方独立行政法人 北松中央病院（長崎県）
・佐世保市立総合病院（長崎県）
・独立行政法人国立病院機構 嬉野医療センター（佐賀県）
・長崎市立市民病院（長崎県）
・医療法人 光晴会病院（長崎県）
・医療法人 栄和会 泉川病院（長崎県）
・健康保険諫早総合病院（長崎県）
・千住診療所（長崎県）
・おにつか内科・消化器科（長崎県）
・医療法人 ともなが内科クリニック（長崎県）
・入船クリニック（長崎県）
・かわむら内科（長崎県）
・重野医院（長崎県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 05 | 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
| 2012 | Year | 11 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 27 | Day |
Last follow-up date
| 2014 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2014 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 04 | Day |
Last modified on
| 2017 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011137
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
