UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019120 |
|---|---|
| Receipt number | R000022108 |
| Scientific Title | Prospective Study in Respiratory Syncytial Virus Infected Japanese Adults, in Outpatient and Inpatient Settings |
| Date of disclosure of the study information | 2015/09/26 |
| Last modified on | 2017/10/02 16:40:39 |
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Basic information
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
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
| 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
odate-rsv@virology.med.tohoku.ac.jp
Public contact
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
ehoutme2@its.jnj.com
Sponsor or person
Institute
Janssen Pharmaceutica NV
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Partially published
Result
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
Progress
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022108
