UMIN-CTR Clinical Trial

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