UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Shigeki Nakamura
Organization	Nagasaki University Hospital
Division name	Second Department of Internal Medicine
Address	1-7-1, Sakamoto, Nagasaki city, Nagasaki prefecture.
TEL	095-819-7273
Email	moju516@nagasaki-u.ac.jp

Public contact
Name of contact person	Taiga Miyazaki
Organization	Nagasaki evaluation organization for clinical interventions
Division name	office
Address	1-7-1, Sakamoto, Nagasaki city, Nagasaki prefecture.
TEL	095-819-7273
Homepage URL
Email	shinkin@peath.co.jp

Sponsor
Institute	Nagasaki evaluation organization for clinical interventions
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 11 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011137