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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020696
Receipt No. R000023698
Scientific Title Safety and efficacy of anti-influenza drugs, intravenous peramivir against influenza virus infected elderly patients with underlying disease
Date of disclosure of the study information 2016/01/23
Last modified on 2016/01/22

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Basic information
Public title Safety and efficacy of anti-influenza drugs, intravenous peramivir against influenza virus infected elderly patients with underlying disease
Acronym Safety and efficacy of peramivir against influenza virus infected elderly patients with underlying disease
Scientific Title Safety and efficacy of anti-influenza drugs, intravenous peramivir against influenza virus infected elderly patients with underlying disease
Scientific Title:Acronym Safety and efficacy of peramivir against influenza virus infected elderly patients with underlying disease
Region
Japan

Condition
Condition Influenza virus infection
Classification by specialty
Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 efficacy of peramivir
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes the time from administration to return to normal temperatures
Key secondary outcomes mortality, adverse events

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
65 months-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patients 65 years or older who had been hospitalized with influenza treated with peramivir during February-2012 March 2015.
Key exclusion criteria outpatients
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takamatsu Kazufumi
Organization Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Division name Department of Respiratory medicine
Zip code
Address 2-4-20 Ohgimachi, Kita-ku, Osaka 530-8480, Japan
TEL 06-6312-1221
Email k-takamastu@kitano-hp.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takamatsu Kazufumi
Organization Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Division name Department of Respiratory medicine
Zip code
Address 2-4-20 Ohgimachi, Kita-ku, Osaka 530-8480, Japan
TEL 06-6312-1221
Homepage URL
Email k-takamastu@kitano-hp.or.jp

Sponsor
Institute Department of Respiratory medicine, Kitano Hospital, The Tazuke Kofukai Medical Research Institute, Osaka, Japan
Institute
Department

Funding Source
Organization no fund
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2016 Year 01 Month 23 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 01 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information It is a retrospective observational study to examine the efficacy and safety of peramivir against influenza elderly patients with underlying disease

Management information
Registered date
2016 Year 01 Month 22 Day
Last modified on
2016 Year 01 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023698

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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