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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000046537
Receipt No. 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

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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
Email 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
Email m05009hi@jichi.ac.jp

Sponsor
Institute Department of Infection Control and Infectious Diseases, Tohoku Medical and Pharmaceutical University Hospital
Institute
Department

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
Email 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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052976

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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