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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026691
Receipt No. R000030645
Scientific Title Mechanism of influenza infection
Date of disclosure of the study information 2017/03/24
Last modified on 2018/10/01

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Basic information
Public title Mechanism of influenza infection
Acronym Mechanism of influenza infection
Scientific Title Mechanism of influenza infection
Scientific Title:Acronym Mechanism of influenza infection
Region
Japan

Condition
Condition influenza
Classification by specialty
Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Influenza virus infects the upper respiratory epithelium and causes influenza. This process needs the proteolytic cleavage of hemagglutinin by trypsin or trypsin-like protease (TLP) to acquire the infectivity (fusion activity) of influenza virus. In this study we focus how influenza acquire infectivity in the infected person to spread infection in the nasopharyngeal mucosa. The nasaopharyngeal swabs of influenza patients is siolated and subjected to virus isolation with/without treatment of trypsin in MDCK cells.
Basic objectives2 Others
Basic objectives -Others Analysis of the mode of acquiring infectivity in the nasopharynx.
Trial characteristics_1 Others
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Determination of viral infectivity in nasopharyngeal swab using MDCK cells. Effects of trypsin treatment of nasopharyngeal swabs on the virus titers would clarify the role of the nasopharyngeal surface.

Effect of subtype of influenza infectivity. Subtype is determined by the sequence and the correlation between infectivity and the sbutype is analyzed.
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 influenza infected patients who agree to join the study.
Key exclusion criteria Patients with difficulty in obtaining nasophryngeal swabs.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kimiyasu Shiraki
Organization University of Toyama
Division name Department of Virology
Zip code
Address 2630 Sugitani, Toyama 930-0194
TEL 076-434-7255
Email kshiraki@med.u-toyama.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kimiyasu Shiraki
Organization University of Toyama
Division name Department of Virology
Zip code
Address 2630 Sugitani, Toyama 930-0194
TEL 076-434-7255
Homepage URL
Email kshiraki@med.u-toyama.ac.jp

Sponsor
Institute University of Toyama
Institute
Department

Funding Source
Organization University of Toyama
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor National Hospital Organization Toyama Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 clinical28-119
Org. issuing International ID_1 University fo Toyama
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 富山大学病院
国立病院機構 富山病院

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 24 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
Nasal swabs from influenza patients were quantitated for virus titer in the presence and absence of trypsin. Some were enhance
 dby trypsin but some were not. The number of samples obtained were too low for evaluation of the rsults, because the recuitment started at the end of the season. Currently 19 specimens were obtained but the number of specimens is not enough for analysis and conclusion. We are preparing for the next season to complete the study.
 We are preparing for collecting the specimens in the coming 201-2019 season.
  
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
2017 Year 01 Month 16 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We analyze the mode of influenza by collecting the swab of infected persons and sharing the samples for diagnosis by the immunochromat method and this analysis under informed consent.

Management information
Registered date
2017 Year 03 Month 24 Day
Last modified on
2018 Year 10 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030645

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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