UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059938 |
|---|---|
| Receipt number | R000068553 |
| Scientific Title | Longitudinal Study aimed at elucidating the relationship between viral load and mucosal antibody in influenza |
| Date of disclosure of the study information | 2025/12/10 |
| Last modified on | 2025/12/02 04:14:58 |
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Basic information
Public title
Study of Short-term Correlation Between Influenza Virus and Antibodies in Nasal Swabs
Acronym
Short-term Correlation in Nasal Swab Influenza Study
Scientific Title
Longitudinal Study aimed at elucidating the relationship between viral load and mucosal antibody in influenza
Scientific Title:Acronym
Influenza Longitudinal Study
Region
| Japan |
Condition
Condition
Influenza
Classification by specialty
| Pneumology | Infectious disease | Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the threshold value of mucosal antibody titer required to suppress virus shedding.
Basic objectives2
Others
Basic objectives -Others
the relationship between viral load and mucosal antibody
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Threshold value based on logistic regression and ROC analysis using specific antibody titer against influenza virus antigen and success/failure of virus isolation test
Key secondary outcomes
- Regression analysis using the number of days from symptom onset until virus isolation test negativity and viral RNA negativity and specific antibody (IgG, IgA, secretory IgA) responses to influenza antigens
- Analysis of the relationship between host RNA and influenza virus viral load and mucosal antibody titers
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Nasopharyngeal swab collection
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
| 16 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Individuals who have completed junior high school or are aged 16 to 80 years at the time of consent.
2) Individuals who have a positive influenza rapid diagnostic test (RAT) using a nasal or nasopharyngeal swab on the day of consent.
3) Individuals who are within four days of the onset of symptoms, counting the first day as the first day. The onset date is defined as any of the following:
a. The day on which the body temperature first rose (a rise of 1 oC or more above normal).
b. The day on which the patient experienced at least one systemic symptom (fever or chills, muscle or joint pain, fatigue) or respiratory symptom (cough, sore throat, headache, runny nose/stuffy nose).
4) Individuals who have received a thorough explanation of this study and provided their own voluntary written consent with a full understanding.
Key exclusion criteria
Persons who fall under any of the following
1) Patients who have used excluded or discontinued medications, such as antiviral drugs, within the past seven days.
2) Patients who are using excluded or discontinued medications, such as antiviral drugs, during their treatment with influenza during study participation.
3) Patients diagnosed with COVID-19.
4) Other individuals deemed inappropriate by the principal investigator.
The following medications will be excluded or discontinued:
I. Drugs that directly inhibit influenza virus replication
1) Neuraminidase inhibitor
Oseltamivir, Zanamivir, Laninamivir, Peramivir
2) Cap-dependent endonuclease inhibitors
Baloxavir marboxil
3) M2 ion channel inhibitors
Amantadine
4) RNA-dependent RNA polymerase inhibitors
Favipiravir
II. Drugs with immunosuppressive effects
1) Injectable, oral, inhaled, and nasal corticosteroids (steroids)
Prednisolone, Methylprednisolone, Dexamethasone, Hydrocortisone, Fluticasone propionate, and other corticosteroids
2) Injectable and oral calcineurin inhibitors
Cyclosporine, Tacrolimus
3) mTOR inhibitors Sirolimus
Everolimus
4) Antimetabolites/Antimetabolites
Azathioprine, Mycophenolate mofetil, Methotrexate
5) Alkylating agents
Cyclophosphamide
6) Immunosuppressive biologics
Rituximab, Belimumab, Abatacept, Basiliximab
7) Molecularly targeted drugs such as JAK inhibitors
Tofacitinib, Baricitinib, Upadacitinib
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Kohtaro |
| Middle name | |
| Last name | Fujihashi |
Organization
Chiba University Hospital
Division name
Department of Human Mucosal Vaccines
Zip code
260-8677
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba
TEL
043-222-7171
kfujihashi@chiba-u.jp
Public contact
Name of contact person
| 1st name | Morio |
| Middle name | |
| Last name | Nagira |
Organization
Chiba University Hospital
Division name
Department of Human Mucosal Vaccines
Zip code
260-8677
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba
TEL
043-222-7171
Homepage URL
morio.nagira@shionogi.co.jp
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Shionogi Co. Ltd.
Japan Institute for Health Security
Name of secondary funder(s)
Shionogi Co. Ltd.
IRB Contact (For public release)
Organization
Chiba University Hospital Observational Research Ethics Review Committee
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba, 260-8677 Japan
Tel
043-222-7171
hsp-kansaturinri@chiba-u.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
かめざわクリニック(愛知県)、医療法人社団 三友会 彩のクリニック(埼玉県) など
Kamezawa Clinic(Aichi Pref.)、Saino Clinic(Saitama Pref.) etc.
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 11 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 12 | Month | 02 | Day |
Last modified on
| 2025 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068553
