UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000026464
Receipt No. R000030399
Scientific Title Clinical utility of rapid diagnositc test in the patients with respiratory tract infection
Date of disclosure of the study information 2017/03/08
Last modified on 2019/03/20

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 Main results already published
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
2019 Year 03 Month 20 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.