UMIN-CTR Clinical Trial

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, 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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039321