UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026691 |
|---|---|
| Receipt number | R000030645 |
| Scientific Title | Mechanism of influenza infection |
| Date of disclosure of the study information | 2017/03/24 |
| Last modified on | 2023/03/09 15:12:46 |
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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 | Kimiyasu |
| Middle name | |
| Last name | Shiraki |
Organization
University of Toyama
Division name
Department of Virology
Zip code
930-0194
Address
2630 Sugitani, Toyama 930-0194
TEL
076-434-7255
kshiraki@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Kimiyasu |
| Middle name | |
| Last name | Shiraki |
Organization
University of Toyama
Division name
Department of Virology
Zip code
930-0194
Address
2630 Sugitani, Toyama 930-0194
TEL
076-434-7255
Homepage URL
kshiraki@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
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
Ethics Committee, University of Toyama
Address
2360 Sugitani ,Toyama, Japan
Tel
076-434-7661
rinri@adm.u-toyama.ac.jp
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. The number of samples needed for analysis were not collected and therefore this project was terminated.
Results date posted
| 2023 | Year | 03 | Month | 09 | Day |
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
Terminated
Date of protocol fixation
| 2017 | Year | 01 | Month | 16 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 30 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 30 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
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
| 2023 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030645
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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