UMIN-CTR Clinical Trial

Basic information
Public title	A Epidemiology Study to Estimate the Attack Rate of Respiratory Syncytial Virus Infection in Older Adults
Acronym	A Epidemiology Study to Estimate the Attack Rate of Respiratory Syncytial Virus Infection in Older Adults
Scientific Title	A Prospective Epidemiology Study to Estimate the Attack Rate of Respiratory Syncytial Virus Infection in Adults Aged 65 Years and Older in Japan
Scientific Title:Acronym	A Prospective Epidemiology Study to Estimate the Attack Rate of Respiratory Syncytial Virus Infection in Adults Aged 65 Years and Older in Japan
Region	Japan

Condition
Condition	Respiratory Syncytial Virus Infections
Classification by specialty	Pneumology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to estimate the attack rate of respiratory syncytial virus (RSV)-acute respiratory disease (ARD) in adults aged 65 years and older in Japan.
Basic objectives2	Others
Basic objectives -Others	The number of Protocol Defined Respiratory Syncytial Virus (RSV)-Acute Respiratory Disease (ARD) Confirmed by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Number of Participants with Protocol Defined Respiratory Syncytial Virus (RSV)-Acute Respiratory Disease (ARD) Confirmed by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) during study period (up to Week 52)
Key secondary outcomes	-Number of Participants with Protocol Defined Respiratory Syncytial Virus(RSV)-Lower Respiratory Tract Disease (LRTD) Confirmed by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) during study period (up to Week 52) -Incidence of Mortality Associated with RSV-ARD -Duration of RSV-ARD -Signs and Symptoms Associated with RSV-ARD -Number of Participants with Hospitalization, Outpatient Visit, and Emergency Room (ER) Visit due to RSV-ARD -Number of Participants with ARD caused by Different Types of Respiratory Pathogens Other Than RSV -Duration of ARD due to Different Types of Respiratory Pathogens Other Than RSV -Signs and Symptoms Associated with ARD Caused by Different Types of Respiratory Pathogens Other Than RSV -Number of Participants with Hospitalization, Outpatient Visit, and Emergency Room (ER) Visit due to ARD Caused by the Different Types of Respiratory Pathogens Other Than RSV -Percentage of Participants with RSV-LRTD by Age-Group, Underlying Comorbidities, Immunosuppression Status, Functional Status and Place of Residence

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	65 years-old <=
Age-upper limit	999 years-old >
Gender	Male and Female
Key inclusion criteria	Participants are ambulatory and live in the community, or in assisted living or long-term care residential facilities that provide minimal assistance, such that the participant is primarily responsible for selfcare and activities of daily living such as: a.) able to take care of all shopping needs independently; b.) able to travel independently; c.)able to operate telephone on their own (make or receive calls); d.) responsible for taking medication in correct dosages at correct time; e.) able to perform daily self-care such as bathing, changing clothes, using toilet and grooming - Participants may have one or more chronic medical diagnoses but should be clinically stable as assessed by absence of known, current, and life-limiting diagnoses which, in the opinion of the investigator,render survival to completion of the protocol unlikely - Willing and able (on both a physical and cognitive basis) to give informed consent prior to study enrollment - Able to comply with study requirements; including access to transportation for study visits
Key exclusion criteria	-Participants received any experimental antiviral drugs or vaccines against respiratory syncytial virus (RSV) within 6 months prior to the signing Informed Consent Form (ICFs) - Participants who have acute respiratory disease (ARD) at the time of ICF and Week 0 (Baseline) at the discretion of the investigator - Participants with life expectancy less than 1 year - Participants unwilling to undergo nasopharyngeal swab procedures or with any physical abnormality which limits the ability to collect regular nasopharyngeal specimens - Participant who is not able to comply with study-related procedures,due to their mental status or severe clinical condition, based on clinical judgement of the investigator
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Hirotaka Middle name Last name Numaguchi
Organization	Janssen Pharmaceutical K.K.
Division name	R&D Clinical Science div. Infectious disease & Vaccine Clinical Development Dept.
Zip code	101-0065
Address	3-5-2 Nishikanda, Chiyoda-ku, Tokyo, Japan
TEL	03-4411-7700
Email	HNumaguc@its.jnj.com

Public contact
Name of contact person	1st name Maho Middle name Last name Yamada
Organization	Janssen Pharmaceutical K.K.
Division name	R&D Clinical Science div. Infectious disease & Vaccine Clinical Development Dept.
Zip code	101-0065
Address	3-5-2 Nishikanda, Chiyoda-ku, Tokyo, Japan
TEL	03-4411-7700
Homepage URL	http://pam.sylogent.com/cr/CR108658
Email	myamada1@its.jnj.com

Sponsor
Institute	Janssen Pharmaceutical K.K. R&D Clinical Science div. Infectious disease & Vaccine Clinical Development Dept.
Institute
Department

Funding Source
Organization	Janssen Pharmaceutical K.K.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kitamachi Clinic Ethic Committee
Address	1-1-3, Kichijoji-Kitamachi, Musashino, Tokyo
Tel	03-6779-8166
Email	shingo-namiki@j-smo.com

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

公益財団法人宮城厚生協会　坂総合病院(宮城県），医療法人社団仁智会　鈴木内科クリニック（東京都），医療法人社団 ささきクリニック（兵庫県），よしむらクリニック（熊本県），医療法人　小田辺内科医院（福岡県），医療法人社団　埼忠禎会　埼葛クリニック（埼玉県），山一ビル内科クリニック（東京都），のぐち内科クリニック（東京都），医療法人社団　山田医院（千葉県），医療法人相生会 ピーエスクリニック（福岡県） ／Saka GeneralHospital(Miyagi),SuzukiClinic Internal Medicine(Tokyo),Sasaki Clinic(Hyogo),Yoshimura Clinic(Kumamoto), Otabe Clinic(Fukuoka), Saikatsu Clinic(Saitama), Yamaichi Building Medical Clinic(Tokyo), Noguchi Naika Clinic(Tokyo), Yamada Clinic(Chiba),SOUSEIKAI PS Clinic(Fukuoka)

Other administrative information
Date of disclosure of the study information	2019 Year 09 Month 02 Day

Related information
URL releasing protocol	https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000042819
Publication of results	Published

Result
URL related to results and publications	http://doi.org/10.1111/irv.12928
Number of participants that the trial has enrolled	1000
Results	Respiratory syncytial virus was reported as a major pathogen for respiratory infection and represents a significant burden in the Japanese elderly population.
Results date posted	2021 Year 05 Month 27 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2021 Year 11 Month 03 Day
Baseline Characteristics	There was a higher proportion of females (551/1,000 [55.1%] subjects) than males (449/1,000 [44.9%] subjects). The median age of all subjects was 74.0 years (range: 65 to 93 years); and more than half of subjects (543/1,000 [54.3%]) were in the age category of 65 to 74 years. The majority of subjects were home residents (996/1,000 [99.6%]), living with family/cohabiter (809/1,000 [(80.9%] subjects), nonsmokers (576/1,000 [57.6%] subjects), and had been vaccinated with influenza vaccine in 2019/2020 (645/1,000 [64.5%] subjects). At baseline, most of the subjects (998/1,000 [99.8%] subjects) had a functional status of >16 evaluated by Barthel Index of Activities of Daily Living. A total of 958/1,000 (95.8%) subjects had at least 1 coexisting medication condition. The most common (reported in >10% of subjects) medical condition was asthma (104/1,000 [10.4%] subjects) among conditions with increased risk for severe RSV. Metabolism and nutrition disorders (646/1,000 [64.6%] subjects) and vascular disorders (576/1,000 [57.6%] subjects) were the most commonly (>50% of subjects) reported coexisting medical conditions by system organ class.
Participant flow	A total of 1,000 subjects were enrolled in the study. Of these, 913 (91.3%) subjects completed the study and 87 (8.7%) discontinued the study. The reasons for discontinuation were consent withdrawal (58 [5.8%] subjects), lost to follow-up (22 [2.2%] subjects), death (6 [0.6%] subjects), and repeated failure to comply with protocol requirements (1 [0.1%] subject). Of the 87 discontinued subjects, 32 (3.2%), 16 (1.6%), and 39 (3.9%) subjects had discontinued before the start of RSV season, during the RSV season, and after the RSV season until the end of the study, respectively. Overall, 313 (31.3%) subjects had 459 ARD visits. A total of 6 subjects discontinued the study due to death, however, none of the subjects died due to AEs associated with nasopharyngeal swab sample collection, RSV-ARD, or ARD caused by different types of respiratory pathogens other than RSV during the whole study period.
Adverse events	Only 1/1,000 (0.1%) subjects had an AE during this study. This subject experienced an AE of epistaxis related to nasopharyngeal swab sampling collection. The outcome of the event was reported as resolved on the same day of onset. None of the subjects had death as an outcome and no subject reported with an SAE during the study.
Outcome measures	Primary endpoint: A total of 24/1,000 (2.4%; 95% CI: 1.54, 3.55) subjects had 1 episode of RSV-ARD; 13/1,000 (1.3%; 95% CI: 0.69, 2.21) and 11/1,000 (1.1%, 95% CI: 0.55, 1.96) subjects had RSV-ARD of Subtype A and Subtype B, respectively. ？ Secondary endpoints: Occurrence of RSV-LRTD: A total of 8/1,000 (0.8%; 95% CI: 0.35, 1.57) subjects had 1 episode of RSV-LRTD which was defined as new onset or worsening of at least 1 symptom of LRTI, assessed by the investigator. Outcome of RSV-ARD: The median (range) duration of RSV-ARD was 18.0 (10 to 33) days. A total of 24/1,000 (2.4%) subjects during the whole study period had utilized the medical services of outpatient visits and 1/24 (4.2%) subjects was hospitalized for 10 days for RSV-ARD. Occurrence of ARD Caused by Different Types of Respiratory Pathogens Other Than RSV: The most common viruses other than RSV that caused ARD (detected in >10 subjects) were human rhinovirus/enterovirus (100/1,000 [10.0%; 95% CI: 8.21, 12.03] subjects), parainfluenza 3 (20/1,000 [2.0%; 95% CI: 1.23, 3.07] subjects), coronavirus OC43 and human metapneumovirus (12/1,000 [1.2%; 95% CI: 0.62, 2.09] subjects each), and influenza A/H1 (11/1,000 [1.1%; 95% CI: 0.55, 1.96] subjects). Only 1 subject reported ARD due to influenza B virus. Outcome of ARD Caused by Different Types of Respiratory Pathogens Other Than RSV: The median (range) duration of ARD (detected in >10 subjects) caused by viruses other than RSV was 20.5 (10 to 36) days for human metapneumovirus, 15.5 (9 to 31) days for parainfluenza 3, 15.0 (5 to 55) days for human rhinovirus/enterovirus, 15.0 (5 to 38) days for influenza A/H1, and 12.5 (6 to 35) days for coronavirus OC43. A total of 93/100 (93.0%) subjects who had ARD due to human rhinovirus/enterovirus; 12/12 (100.0%) subjects each due to coronavirus OC43 and human metapneumovirus; 17/20 (85.0%) subjects due to parainfluenza 3; 9/11 (81.8%) subjects due to influenza A/H1 had utilized the medical service of outpatient visit. One subject each who had ARD due to human metapneumovirus and influenza A/H1 was hospitalized.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 01 Month 11 Day
Date of IRB	2019 Year 03 Month 20 Day
Anticipated trial start date	2019 Year 04 Month 11 Day
Last follow-up date	2020 Year 07 Month 06 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This is prospective observational cohort study. Recruitment had been conducted at clinical study institutions and had been completed.

Management information
Registered date	2019 Year 09 Month 02 Day
Last modified on	2021 Year 12 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042819