UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046537 |
|---|---|
| Receipt number | R000052976 |
| Scientific Title | Analysis of microorganisms causing acute upper respiratory tract infection using a multiplex polymerase chain reaction during COVID-19 epidemic |
| Date of disclosure of the study information | 2022/01/11 |
| Last modified on | 2022/01/04 19:17:25 |
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Basic information
Public title
Analysis of causative microorganisms of upper respiratory tract inflammation using Film array
Acronym
Analysis of causative microorganisms of upper respiratory tract inflammation using FA
Scientific Title
Analysis of microorganisms causing acute upper respiratory tract infection using a multiplex polymerase chain reaction during COVID-19 epidemic
Scientific Title:Acronym
Analysis of microorganisms causing acute upper respiratory tract infection using a multiplex polymerase chain reaction during COVID-19 epidemic
Region
| Japan |
Condition
Condition
upper respiratory tract inflammation
Classification by specialty
| Infectious disease | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Epidemiology of microorganisms causing upper respiratory tract infection under COVID-19 epidemic
Basic objectives2
Others
Basic objectives -Others
Epidemiology of microorganisms causing upper respiratory tract infection under COVID-19 epidemic
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Epidemiology of microorganisms causing upper respiratory tract infection
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
Outpatients with consent for testing
Key exclusion criteria
Cases judged to require hospitalization, urinary tract infections and gastroenteritis that are not similarly diagnosed as upper respiratory tract infections
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Haruka |
| Middle name | |
| Last name | Imai |
Organization
Tohoku Medical and Pharmaceutical University
Division name
Division of Infectious Diseases and Infection Control, Faculty of Medicine
Zip code
9838536
Address
1-15-1 Fukumuro, Miyagino-ku, Sendai City, Miyagi, Japan
TEL
0222908850
m05009hi@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Haruka |
| Middle name | |
| Last name | Imai |
Organization
Tohoku Medical and Pharmaceutical University
Division name
Division of Infectious Diseases and Infection Control, Faculty of Medicine
Zip code
9838536
Address
1-15-1 Fukumuro, Miyagino-ku, Sendai City, Miyagi, Japan
TEL
0222908850
Homepage URL
m05009hi@jichi.ac.jp
Sponsor or person
Institute
Department of Infection Control and Infectious Diseases, Tohoku Medical and Pharmaceutical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Infection Control and Infectious Diseases, Tohoku Medical and Pharmaceutical University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Tohoku Medical and Pharmaceutical University
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku Medical and Pharmaceutical University Hospital
Address
15-1, Fukumuro 1-chome, Miyagino-ku, Sendai City
Tel
0222908850
m05009hi@jichi.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
| 2022 | Year | 01 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
411
Results
The most common diagnosis was acute upper respiratory tract infection (344/411), followed by acute bronchitis or pneumonia and pharyngitis. The most common causative microorganism of upper respiratory tract infection was Coronavirus NL63 (46/344: 13.4%), followed by Rhinovirus / Enterovirus (12.2%) and SARS-CoV-2 (1.7%). On the other hand, SARS-CoV-2 (11/43: 25.6%) was the most common virus causing acute bronchitis or pneumonia.
Results date posted
| 2022 | Year | 01 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We reviewed the medical records of all patients who visited the outpatient clinic between November 1, 2020 and May 31, 2021, and who consented to the BioFire Respiratory Panel 2.1 test. Of these, patients admitted to the hospital with conditions other than COVID-19 and those diagnosed with urinary tract infections or gastroenteritis were excluded. The study population consisted of patients diagnosed with upper respiratory tract infections, bronchitis/pneumonia, pharyngitis, and sinusitis who were being treated as outpatients.
The review included details of the diagnosis and treatment, including antimicrobial administration. The overuse of antibiotics in patients with upper respiratory tract infections is a global problem and is unnecessary in the pathogenesis of the disease, and therefore, we defined the administration of antibiotics for upper respiratory tract infections as inappropriate antibiotics. These patients presented to the clinic with general symptoms, such as fever, cough, sore throat, nasal discharge, malaise, dyspnea, sputum, and headache, along with other symptoms
Participant flow
They were examined when they visited our hospital because they had symptoms of upper respiratory tract infection. Hospitalized patients Inpatients were excluded from the study. Those who were diagnosed with urinary tract infection as a result of outpatient examination were excluded.
Adverse events
Nothing
Outcome measures
Causative Microorganisms of Upper Respiratory Inflammation
Plan to share IPD
Nothing
IPD sharing Plan description
Nothing
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
We collected specimens from the nasopharynx of 411 outpatients who visited our hospital for upper respiratory tract infection symptoms from November 2020 to May 2021 and analyzed them using the BioFire Respiratory Panel, a multiplex polymerase chain reaction system.
Management information
Registered date
| 2022 | Year | 01 | Month | 04 | Day |
Last modified on
| 2022 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052976
