UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042945
Receipt number R000049012
Scientific Title Influenza viral shedding after treatment with and anti-influenza drug
Date of disclosure of the study information 2021/01/08
Last modified on 2021/11/02 10:27:37

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Basic information

Public title

Influenza viral shedding after treatment with and anti-influenza drug

Acronym

Influenza viral shedding after treatment with and anti-influenza drug

Scientific Title

Influenza viral shedding after treatment with and anti-influenza drug

Scientific Title:Acronym

Influenza viral shedding after treatment with and anti-influenza drug

Region

Japan


Condition

Condition

Influenza

Classification by specialty

Medicine in general Infectious disease

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate viral persistence after treatment with an anti-influenza drug

Basic objectives2

Others

Basic objectives -Others

To investigate viral persistence after treatment with an anti-influenza drug

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Virus detection rate by virus culture at day 5 and/or day 10 after treatment with an anti-influenza drug

Key secondary outcomes



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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients diagnosed as influenza with a rapid antigen detection kit

Key exclusion criteria

None

Target sample size

300


Research contact person

Name of lead principal investigator

1st name Koichi
Middle name
Last name Mochizuki

Organization

Japan Physicians Association

Division name

None

Zip code

101-0062

Address

2-5 Tokyo Medeical Association Bld. Kandasurugadai, Chiyoda-ku, Tokyo 101-0062

TEL

03-3259-6111

Email

jpa@nichirinnai.jp


Public contact

Name of contact person

1st name Chigusa
Middle name
Last name Iwasaki

Organization

RICERCA CLINICA Co.,Ltd

Division name

Clinical support center

Zip code

812-0013

Address

2-18-30 Yaesuhakata Bld.6F, Hakataeki Higashi, Hakata-ku, Fukuoka-shi, Fukuoka, 812-0013

TEL

092-435-1150

Homepage URL


Email

secretary@ricercaclinica.jp


Sponsor or person

Institute

Japan Physicians Association Influenza Study Group

Institute

Department

Personal name



Funding Source

Organization

SHIONOGI & CO., LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Haradoi Hospital

Address

6-40-8, Aoba, Higashi-ku, Fukuoka-shi, Fukuo ka 813-8588

Tel

0120-372-891

Email

irb@haradoi-hospital.com


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

2021 Year 01 Month 08 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

2020 Year 09 Month 04 Day

Date of IRB

2020 Year 10 Month 06 Day

Anticipated trial start date

2021 Year 01 Month 06 Day

Last follow-up date

2021 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Influenza viral shedding after treatment with and anti-influenza drug


Management information

Registered date

2021 Year 01 Month 08 Day

Last modified on

2021 Year 11 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049012


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name