UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038276 |
|---|---|
| Receipt number | R000043628 |
| Scientific Title | Evaluation of rapid diagnostic test in the patients with influenza |
| Date of disclosure of the study information | 2020/01/01 |
| Last modified on | 2022/10/13 04:00:47 |
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Basic information
Public title
Evaluation of rapid diagnostic test in the patients with influenza
Acronym
Evaluation of rapid diagnostic test in the patients with influenza
Scientific Title
Evaluation of rapid diagnostic test in the patients with influenza
Scientific Title:Acronym
Evaluation of rapid diagnostic test in the patients with influenza
Region
| Japan |
Condition
Condition
Influenza
Classification by specialty
| Medicine in general | Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate novel rapid diagnostic test for influenza
Basic objectives2
Others
Basic objectives -Others
Detection rate
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
We calculated sensitivity, specificity, ROC curve, and AUC of novel rapid diagnostic test for influenza, and compared with antigen test.
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
Patient who have the symptom of influenza and are performed antigen test.
Key exclusion criteria
Patient who was administered anti-influenza agents within one month.
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | Katsunori |
| Middle name | |
| Last name | Yanagihara |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Laboratory Medicine
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki City, Nagasaki, Japan
TEL
095-819-7200
k-yanagi@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Norihito |
| Middle name | |
| Last name | Kaku |
Organization
Nagasaki University Hospital
Division name
Department of Laboratory Medicine
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki City, Nagasaki, Japan
TEL
095-819-7200
Homepage URL
kaku-ngs@umin.ac.jp
Sponsor or person
Institute
Department of Laboratory Medicine, Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Tosoh Corporation
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
Nagasaki University Hospital
Address
1-7-1 Sakamoto, Nagasaki city, Nagasaki, Japan
Tel
095-819-7905
gaibushikin@ml.nagasaki-u.ac.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 | 01 | Day |
Related information
URL releasing protocol
https://www.medrxiv.org/content/10.1101/2022.06.03.22275936v3
Publication of results
Published
Result
URL related to results and publications
https://www.medrxiv.org/content/10.1101/2022.06.03.22275936v3
Number of participants that the trial has enrolled
244
Results
In nasopharyngeal swabs, based on the combined RT-PCR and sequencing results, the sensitivity, specificity, PPV, and NPV of TRC for influenza detection were 0.990, 1.000, 1.000, and 0.993, respectively. In the gargle samples, the sensitivity, specificity, PPV, and NPV of the TRC for detecting influenza were 0.970, 0.982, 0.980, and 0.974, respectively.
Results date posted
| 2022 | Year | 10 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with influenza-like illness
Participant flow
After obtaining informed consent, nasopharyngeal swabs and gargle samples were collected. Nasopharyngeal swabs were collected from all the patients using two swabs. Gargle samples were collected from patients whom the physician judged to be able to perform gargling.
Adverse events
None
Outcome measures
Based on the combined RT-PCR and sequencing results, the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of TRC for influenza detection were calculated.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 17 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 17 | Day |
Last follow-up date
| 2021 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2019 | Year | 10 | Month | 11 | Day |
Last modified on
| 2022 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043628
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