UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037477 |
|---|---|
| Receipt number | R000042724 |
| Scientific Title | Evaluation of rapid diagnostic test for RS virus and adenovirus infection |
| Date of disclosure of the study information | 2021/08/01 |
| Last modified on | 2024/01/25 09:47:08 |
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Basic information
Public title
Performance evaluation test of rapid diagnostic kit for testing RS virus and adenovirus infection
Acronym
Evaluation of rapid diagnostic test for RS virus and adenovirus infection
Scientific Title
Evaluation of rapid diagnostic test for RS virus and adenovirus infection
Scientific Title:Acronym
Evaluation of rapid diagnostic test for RS virus and adenovirus infection
Region
| Japan |
Condition
Condition
respiratory syncytial virus (RSV) infection, adenovirus infection
Classification by specialty
| Infectious disease | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of rapid diagnostic test for RS virus and adenovirus infection
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensitivity, specificity and detection limit of rapid diagnostic test for RS virus and adenovirus infection
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver | Other |
Interventions/Control_1
Sample collection, assay with test kit
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
Patients that visit the medical institution during this study, and include the following conditions:
1) Patients with suspected RSV or Adeno virus infection based on symptoms.
2) Patients who agree to participate in this study.
Key exclusion criteria
1) Patients who are difficult to obtain clinical samples from.
2) For any reason other than above, patients who were determined by doctor as being unfit to participate in this study.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Keiko |
| Middle name | |
| Last name | Mitamura |
Organization
Eiju General Hospital
Division name
Division for infection control
Zip code
110-8645
Address
2-23-16 Higashi-ueno, Taito-ku Tokyo 110-8645, Japan
TEL
03-3833-8381
mitamurakeiko77@gmail.com
Public contact
Name of contact person
| 1st name | Yuta |
| Middle name | |
| Last name | Maehara |
Organization
Sekisui Medical Co., Ltd.
Division name
Research & Development
Zip code
103-0027
Address
1-3 Nihonbashi 2-chome, Chuo-ku Tokyo 103-0027, Japan
TEL
03-3272-0677
Homepage URL
yuta.maehara@sekisui.com
Sponsor or person
Institute
Sekisui Medical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Sekisui Medical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Zama Children's Clinic, Ichikawa Children's Clinic, Abe Children's Clinic, Kobayashi International Clinic, Koukan Clinic, Jichi Medical University
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
座間小児科診療所（神奈川県）、市川こどもクリニック（神奈川県）、あべこどもクリニック（神奈川県）、小林国際クリニック（神奈川県）、こうかんクリニック（神奈川県）、自治医科大学（栃木県）、永寿総合病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.info.pmda.go.jp/tgo/pack/30400EZX00022000_B_01_02/
Publication of results
Published
Result
URL related to results and publications
https://www.info.pmda.go.jp/tgo/pack/30400EZX00022000_B_01_02/
Number of participants that the trial has enrolled
691
Results
1) Control method: PCR
Positive predictive value (sensitivity)
RSV: 90.2~97.8%
Adeno: 91.2~94.1%
Negative concordance (specificity)
RSV: 100%
Adeno: 99.5~100%
2) Control method: Approved products
Positive predictive value (sensitivity)
RSV: 93.3~97.2%
Adeno: 98.0~100%
Negative concordance (specificity)
RSV: 97.0~99.1%
Adeno: 99.5
Results date posted
| 2024 | Year | 01 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
NA
Participant flow
Specimens were collected from patients who obtained consent using the informed consent form and used for testing.
Adverse events
NA
Outcome measures
positive concordance rate
negative concordance rate
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 06 | Month | 24 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 12 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 07 | Month | 24 | Day |
Last modified on
| 2024 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042724
