UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035281 |
|---|---|
| Receipt number | R000039321 |
| Scientific Title | Analytical and Clinical Evaluation of a Point-of-Care Rapid Molecular Detection System for the Influenza Virus |
| Date of disclosure of the study information | 2018/12/17 |
| Last modified on | 2020/07/25 09:27:05 |
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Basic information
Public title
Analytical and Clinical Evaluation of a Point-of-Care Rapid Molecular Detection System for the Influenza Virus
Acronym
Utility of a Point-of-Care Rapid Molecular Detection System for the Influenza Virus
Scientific Title
Analytical and Clinical Evaluation of a Point-of-Care Rapid Molecular Detection System for the Influenza Virus
Scientific Title:Acronym
Utility of a Point-of-Care Rapid Molecular Detection System for the Influenza Virus
Region
| Japan |
Condition
Condition
Respiratory Tract Infection/Influenza
Classification by specialty
| Medicine in general | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the analytical and clinical utility of a point-of-care rapid molecular detection system for the influenza virus.
Basic objectives2
Others
Basic objectives -Others
Another purpose of this study is to examine the agreement between the disease probabilities for influenza assessed by physicians and the results of an antigen testing or a point-of-care rapid molecular detection system for influenza.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of the diagnostic performance of the cobas Liat system and the cobas Influenza A/B & RSV assay (Roche Diagnostics) for the diagnosis of influenza.
Key secondary outcomes
1) Evaluation of the sensitivity and specificity of antigen testing for the diagnosis of influenza
2) To clarify factors that influence the diagnostic performance (sensitivity and specificity) of influenza antigen testing
3) To examine the agreement between the clinical assessment of disease probabilities for influenza and the results of antigen testing or the cobas Liat system
4) To investigate the validity of decisions on work restrictions among health care workers suspected of having influenza
5) To investigate the pattern of anti-influenza drug prescriptions among patients suspected of having influenza
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 are included if all the following criteria are met:
1) Patients suspected with influenza
2) Patients who physicians consider eligible for an antigen test
3) Patients who provide written informed consent
Key exclusion criteria
Patients are excluded if they are unable to communicate effectively in Japanese.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Hiromichi |
| Middle name | |
| Last name | Suzuki |
Organization
Tsukuba Medical Center Hospital
Division name
Division of Infectious Diseases, Department of Medicine
Zip code
3058558
Address
1-3-1, Amakubo, Tsukuba, Ibaraki, Japan
TEL
029-851-3511
hsuzuki@tmch.or.jp
Public contact
Name of contact person
| 1st name | Ishikawa |
| Middle name | |
| Last name | Hiroichi |
Organization
Tsukuba Medical Center Hospital
Division name
Department of Respiratory Medicine
Zip code
3058558
Address
1-3-1, Amakubo, Tsukuba, Ibaraki, Japan
TEL
029-851-3511
Homepage URL
hishikawa@tmch.or.jp
Sponsor or person
Institute
Tsukuba Medical Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Roche diagnostics (Japan)
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
Tsukuba Medical Center Hospital
Address
1-3-1, Amakubo, Tsukuba, Ibaraki, Japan
Tel
029-851-3511
hishikawa@tmch.or.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
| 2018 | Year | 12 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2017 | Year | 11 | Month | 24 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 24 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Collected variables
*Patients' demographic data
Age, sex, comorbidities, influenza vaccination history, close contact with cases of confirmed influenza, and requirement of hospitalization, occupation
*Signs
Coughs; feverishness or chills; sore throat; muscle ache or arthralgia; headache; nasal discharge; nasal congestion; fatigue; diarrhea; the date of the onset of fever and highest temperature (degrees and date); the date of the onset of fever, chills, or subjective fever; the date of the onset of other symptoms related to the current illness
*Physical signs
Conjunctivitis, reddishness of throat or tonsils, tonsillar swelling, tonsillar exudate, cervical lymphadenopathy, posterior pharyngeal wall follicles, chest auscultation
*Others
Clinical assessment of disease probabilities for influenza
Results of nested-PCR for the detection of influenza virus using residual samples
Decisions about work restrictions among healthcare workers suspected of having influenza
Decisions about the prescriptions of anti-influenza drugs
Management information
Registered date
| 2018 | Year | 12 | Month | 17 | Day |
Last modified on
| 2020 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039321
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
