UMIN-CTR Clinical Trial

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

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

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

Primary outcomes

The improvement in clinical status ( improvement ratio )

Key secondary outcomes

The time to alleviation of influenza symptoms.
Incidence of influenza-related complications.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Department of Clinical Infectious Diseases, Aichi Medical University Hospital

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2011

Year

02

Month

03

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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)

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