UMIN-CTR Clinical Trial

Public title

Prospective Study in Respiratory Syncytial Virus Infected Japanese Adults, in Outpatient and Inpatient Settings

Acronym

Prospective Study for RSV infection in Japanese Adults

Scientific Title

Prospective Study in Respiratory Syncytial Virus Infected Japanese Adults, in Outpatient and Inpatient Settings

Scientific Title:Acronym

Prospective Study for RSV infection in Japanese Adults

Region

Japan

Condition

acute respiratory infection

Classification by specialty

Infectious disease

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Dr. Oshitani

Organization

Tohoku University Graduate School of Medicine

Division name

Department of Virology

Zip code

Address

2-1 Seiryo-machi, Aoba-ku, Sendai, 980-8575, Miyagi, Japan

TEL

81227178210

Email

odate-rsv@virology.med.tohoku.ac.jp

Name of contact person

1st name
Middle name
Last name	Houtmeyers Els

Organization

J&J

Division name

Janssen Infectious Diseases-Diagnostics BVBA

Zip code

Address

Turnhoutseweg 30 / 2340 Beerse / Belgium

TEL

+81-032472802560

Homepage URL

Email

ehoutme2@its.jnj.com

Institute

Janssen Pharmaceutica NV

Institute

Department

Personal name

Organization

Janssen Sciences Ireland UC

Organization

Division

Category of Funding Organization

Outside Japan

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Date of disclosure of the study information

2015

Year

09

Month

26

Day

URL releasing protocol

Publication of results

Partially published

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Terminated

Date of protocol fixation

2015

Year

09

Month

25

Day

Date of IRB

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

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

Registered date

2015

Year

09

Month

26

Day

Last modified on

2017

Year

10

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022108