UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026464 |
|---|---|
| Receipt number | 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 | 2021/02/15 11:21:32 |
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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
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
kaku-ngs@umin.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030399
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| Registered date | File name |
| Research case data | |
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