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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035281
Receipt No. 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 2019/10/20

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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
Email 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
Email hishikawa@tmch.or.jp

Sponsor
Institute Tsukuba Medical Center Hospital
Institute
Department

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
Email 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, 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
2019 Year 10 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039321

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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