UMIN-CTR Clinical Trial

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
Email	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
Email	kaku-ngs@umin.ac.jp

Sponsor
Institute	Department of Laboratory Medicine, Nagasaki University Hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043628