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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000039089
Receipt No. R000040944
Scientific Title The effect of anti-influenza drugs on household transmission in Japanese patients with influenza A and B infection: A prospective, observational study
Date of disclosure of the study information 2020/01/09
Last modified on 2020/01/08

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Basic information
Public title The effect of anti-influenza drugs on household transmission in Japanese patients with influenza A and B
infection: A prospective, observational study
Acronym The effect of anti-influenza drugs on household transmission in Japanese patients with influenza A and B
infection
Scientific Title The effect of anti-influenza drugs on household transmission in Japanese patients with influenza A and B
infection: A prospective, observational study
Scientific Title:Acronym The effect of anti-influenza drugs on household transmission in Japanese patients with influenza A and B
infection
Region
Japan

Condition
Condition Patients of any age who are diagnosed with influenza A (subtypes A/H1pdm or A/H3) or B using rapid influenza diagnostic tests (RIDTs) were eligible for inclusion
Classification by specialty
Medicine in general Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 By using medical information in Hirotsu clinic, to evaluate the rate of influenza transmission within households new drug:Cap-dependent endonuclease inhibitor and neuraminidase inhibitors are treated, and compare them between drugs. The effects of prognostic factors(generation, age, family structure, time to start treatment from the onset) on them are also evaluated.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Daily secondary infection rate
Key secondary outcomes Rate of household members with
secondary infections

Proportion of households with
secondary infections

Time to return to normal body temperature (no relapse at least 12hrs continuously)

Time to return to normal body temperature (no relapse at least 72hrs continuously)


Relapse of fever

Time to alleviation of symptoms (6symptoms)

Exploratory analysis of new symptomatic index

Safety

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 of any age who were diagnosed with influenza A (subtypes A/H1pdm or A/H3) or B using RIDTs
Key exclusion criteria Not applicable
Target sample size 1300

Research contact person
Name of lead principal investigator
1st name Nobuo
Middle name
Last name Hirotsu
Organization Hirotsu Clinic, Director
Division name Internal Medicine, Pediatrics
Zip code 2130011
Address Hisamoto 3-6-1-212, Takatsu-ku, Kawasaki-shi, Kanagawa, 231-0011, Japan
TEL 044-822-1933
Email non@hirotsu.ptu.jp

Public contact
Name of contact person
1st name Nobuo
Middle name
Last name Hirotsu
Organization Hirotsu Clinic
Division name Internal Medicine, Pediatrics
Zip code 2130011
Address Hisamoto 3-6-1-212, Takatsu-ku, Kawasaki-shi, Kanagawa, 231-0011, Japan
TEL 044-822-1933
Homepage URL
Email non@hirotsu.ptu.jp

Sponsor
Institute Shionogi & Co.,ltd

Medical affairs department
Institute
Department

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 Meiwa hospital
Address 1-18 Kandasuda Chiyoda-Ku, Tokyo
Tel +81-3-5543-0196
Email shuji.nakamura@smo-msr.co.jp

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
2020 Year 01 Month 09 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 Open public recruiting
Date of protocol fixation
2019 Year 01 Month 26 Day
Date of IRB
2019 Year 01 Month 26 Day
Anticipated trial start date
2019 Year 01 Month 26 Day
Last follow-up date
2023 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information No information about other clinical sites because of single-center study

Management information
Registered date
2020 Year 01 Month 08 Day
Last modified on
2020 Year 01 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040944

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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