UMIN-CTR Clinical Trial

Basic information
Public title	Clinical utility of rapid diagnositc test in the patients with respiratory tract infection
Acronym	Clinical utility of rapid diagnositc test in the patients with respiratory tract infection
Scientific Title	Clinical utility of rapid diagnositc test in the patients with respiratory tract infection
Scientific Title:Acronym	Clinical utility of rapid diagnositc test in the patients with respiratory tract infection
Region	Japan

Condition
Condition	Respiratory tract infection
Classification by specialty	Pneumology Laboratory medicine Emergency medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Verification of utility of rapid diagnostic test
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Concrdance rate of rapid diagnostic test with clinical diagnosis
Key secondary outcomes	Comparison of sensitivity and specificity between rapid diagnostic test with antigen test

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	The patients with respiratory symptom
Key exclusion criteria	The patients wit bleeding tendency
Target sample size	50

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 Laboratry Medicine
Zip code	852-8501
Address	1-7-1 Sakamoto, Nagasaki city, Nagasaki, Japan
TEL	095-819-7574
Email	k-yanagi@nagasaki-u.ac.jp

Public contact
Name of contact person	1st name Norihito Middle name Last name Kaku
Organization	Nagasaki University Graduate School of Biomedical Sciences
Division name	Department of Laboratry Medicine
Zip code	852-8501
Address	1-7-1 Sakamoto, Nagasaki city, Nagasaki, Japan
TEL	095-819-7574
Homepage URL
Email	kaku-ngs@umin.ac.jp

Sponsor
Institute	Nagasaki University
Institute
Department

Funding Source
Organization	SYSMEX bioMerieux Co.,Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Japanese Red Cross Nagasaki Genbaku Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nagasaki University Hospital
Address	1-7-1, Sakamoto, Nagasaki city
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	2017 Year 03 Month 08 Day

Related information
URL releasing protocol	UMIN000026464
Publication of results	Published

Result
URL related to results and publications	https://www.sciencedirect.com/science/article/pii/S1341321X1830151X?via%3Dihub
Number of participants that the trial has enrolled	50
Results	Fifty patients were enrolled. FilmArray RP detected the pathogens in 28 patients. The common pathogens were influenza virus (n = 14), respiratory syncytial virus (n = 6), and human rhinovirus (n = 6). Of the 14 patients with influenza virus, 6 were negative for the antigen test. The physicians diagnosed and treated the patients without the result of FilmArray in this study. Of the patients with positive FilmArray RP, 9 were treated with antibiotics; however, bacteria were detected in only 3 patients.
Results date posted	2019 Year 03 Month 20 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	This was a prospective observational study in influenza epidemics that enrolled adult outpatients who visited a hospital with respiratory tract infection symptoms.
Participant flow	We enrolled adult outpatients who visited the Department of Respiratory Medicine and the Japanese Red Cross Nagasaki Genbaku Hospital with respiratory tract infection symptoms such as cough, sputum, sore throat, nasal mucus, headache, dyspnea, or hypoxemia. Based on the physician's discretion, chest X-ray and microorganism tests, such as gram stain, culture, and influenza antigen test, were performed at the Japanese Red Cross Nagasaki Genbaku Hospital. Informed consent and nasopharyngeal swabs for FilmArray RP were obtained from all patients. The FilmArray RP analysis was performed at Nagasaki University Hospital; however, the results were not reported to the physicians.
Adverse events	No adverse events
Outcome measures	Detection of Viruses
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 11 Month 10 Day
Date of IRB	2015 Year 12 Month 19 Day
Anticipated trial start date	2016 Year 01 Month 01 Day
Last follow-up date	2016 Year 04 Month 30 Day
Date of closure to data entry	2016 Year 04 Month 30 Day
Date trial data considered complete	2017 Year 03 Month 31 Day
Date analysis concluded	2017 Year 03 Month 31 Day

Other
Other related information	The results of rapid diagnostic test do not report to the physicians. We compare the result of rapid diagnostic test with clinical diagnosis by the physicians.

Management information
Registered date	2017 Year 03 Month 08 Day
Last modified on	2021 Year 02 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030399