UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective Study in Respiratory Syncytial Virus Infected Japanese Adults, in Outpatient and Inpatient Settings
Title of the study (Brief title)	Prospective Study for RSV infection in Japanese Adults
Region	Japan

Condition
Condition	acute respiratory infection
Classification by specialty	Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Assess the viral load at screening (for inpatients and outpatients) and the rate of RSV viral clearance (for inpatients), based on the viral load measured in nasal samples.
Basic objectives2	Others
Basic objectives -Others	Assess the Clinical Symptom Score (CSS) based on the clinical assessment.
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Assess the viral load at screening (for inpatients and outpatients) and the rate of RSV viral clearance (for inpatients), based on the viral load measured in nasal samples.
Key secondary outcomes	Assess the Clinical Symptom Score (CSS) based on clinical assessment

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	50 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patient is able to provide written informed consent prior to any study-related procedure(s). 2. Patient is capable to be compliant with the study related procedures, including being interviewed by phone. 3. Patient is 50y or older. 4. Patient is an inpatient OR patient is an outpatient, presenting for medical support to the emergency room, or outpatient clinic or in a private office. 5. For participation to the screening phase, patient is diagnosed with an ARI during the RSV season. The diagnosis of ARI will follow the standard medical procedure. 6. The onset of the acute respiratory symptoms was less than 7 days or 7 days ago. The time from initiation of clinical symptoms will refer to any of the following symptoms occurring or worsening due to the ARI: rhinorrhea, nasal congestion, pharyngitis, cough, difficult breathing or dyspnea, whatever occurs first. 7. Patient diagnosed with ARI can have associated complications such as but not limited to: acute exacerbation of asthma or chronic obstructive pulmonary disease, malignancy, hypoxemia, congestive heart failure, sepsis, septic shock, etc. 8. Patients with co-infections will not be excluded. However, patients identified with a Flu rapid assay as having flu will be excluded. Patients diagnosed with both RSV and Flu using the Idylla assay or PCR-based equivalent will not be excluded. 9. For participation to the assessment phase (just for inpatients) and to the remote monitoring phase (for inpatients and outpatients), patients will have a positive RSV test. Results of the RSV-PCR based test will be available within maximum 24h after screening for inpatients and within maximum 72h after screening for outpatients.
Key exclusion criteria	1. Patient participates in another clinical study, with the exception of registry and epidemiology studies, involving minimum sampling done prior to the patient screening for the proposed study. 2. Patient is not able to provide informed consent prior to any study-related procedure(s), due to the mental status or severe clinical condition. 3. Patient has known dementia. 4. The onset of the acute respiratory symptoms was >7 days ago.
Target sample size	100

Research contact person
Name of lead principal investigator	Dr. Oshitani
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Virology
Address	2-1 Seiryo-machi, Aoba-ku, Sendai, 980-8575, Miyagi, Japan
TEL	81227178210
Email	odate-rsv@virology.med.tohoku.ac.jp

Public contact
Name of contact person	Houtmeyers Els
Organization	J&J
Division name	Janssen Infectious Diseases-Diagnostics BVBA
Address	Turnhoutseweg 30 / 2340 Beerse / Belgium
TEL	+81-032472802560
Homepage URL
Email	ehoutme2@its.jnj.com

Sponsor
Institute	Janssen Pharmaceutica NV
Institute
Department

Funding Source
Organization	Janssen Sciences Ireland UC
Organization
Division
Category of Funding Organization	Outside Japan
Nationality of Funding Organization

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

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

1) Tohoku University (Sendai), Contact: Hitoshi Oshitani 2) Ishinomaki Red Cross Hospital (Ishinomaki), Contact: Masaru Yanai 3) Odate Municipal General Hospital (Odate), Contact: Yoshihiro Takahashi 4) Akita Rosai Hospital (Odate), Contact: Toru Sasaki 5) Odate Municipal Ougita Hospital (Odate), Contact: Naoki Ohmoto 6) Yokohama City University Hospital (Yokohama), Contact: Masaharu Shinkai 7) Yokohama City University Medical Center (Yokohama), Contact: Nobuaki Kobayashi

Other administrative information
Date of disclosure of the study information	2015 Year 09 Month 26 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 09 Month 25 Day
Anticipated trial start date	2015 Year 10 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information	nasal swabs, blood samples, questionnaires and other relevant clinical information with respect to RSV will be collected with respect to viral load and Clinical symptom score recruitment of inpatients and outpatients who will come between Oct 2015 and Mar 2016 and match the inclusion and exclusion criteria at the Odate hospitals (linked to University of Tokyo hospital) as well as the Ishinomaki Red Cross hospital

Management information
Registered date	2015 Year 09 Month 26 Day
Last modified on	2017 Year 10 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022108