UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041828 |
|---|---|
| Receipt number | R000047749 |
| Scientific Title | Clinical study to evaluate the Bordetella pertussis antigen kit for patients suspected to be infected with Bordetella pertussis |
| Date of disclosure of the study information | 2020/10/01 |
| Last modified on | 2020/09/17 19:00:20 |
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Basic information
Public title
Clinical study to evaluate the Bordetella pertussis antigen kit for patients suspected to be infected with Bordetella pertussis
Acronym
Clinical study to evaluate the Bordetella pertussis antigen kit for patients suspected to be infected with Bordetella pertussis
Scientific Title
Clinical study to evaluate the Bordetella pertussis antigen kit for patients suspected to be infected with Bordetella pertussis
Scientific Title:Acronym
Clinical study to evaluate the Bordetella pertussis antigen kit for patients suspected to be infected with Bordetella pertussis
Region
| Japan |
Condition
Condition
Whooping cough
Classification by specialty
| Pneumology | Infectious disease | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the usefulness of the B. pertussis antigen kit with nasopharyngeal swabs from patients suspected to be infected with Bordetella pertussis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlative evaluation of the antigen kit with each result of real-time PCR assay and culture testing.
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients suspected to be infected with Bordetella pertussis, who meet the following 1.1 or 1.2.
1.1 Patients who have cough and presents the following characteristic symptoms more than one, paroxysms, whoop, post-tussive vomiting or apnea.
1.2 Patients who have had contact with infected people.
2. Patients with written consent. In a minor, a patient who can obtain written consent from a legal representative.
Key exclusion criteria
1. Patients who refuse to collect nasopharyngeal swabs.
2. Patients who doctors judge to be inappropriate to participate in the study.
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Okada |
Organization
Fukuoka Nursing College
Division name
Division of Basic Nursing
Zip code
814-0193
Address
2-15-1 Tamura, Sawara-ku, Fukuoka, Japan
TEL
092-801-0411
okadak@college.fdcnet.ac.jp
Public contact
Name of contact person
| 1st name | Tooru |
| Middle name | |
| Last name | Hayakawa |
Organization
Asahi Kasei Pharma Corporation
Division name
Diagnostics dept
Zip code
100-0006
Address
1-1-2 Yurakucho, Chiyoda-ku, Tokyo, Japan
TEL
03-6699-3617
Homepage URL
hayakawa.th@om.asahi-kasei.co.jp
Sponsor or person
Institute
Asahi Kasei Pharma Corporation
Institute
Department
Personal name
Funding Source
Organization
Asahi Kasei Pharma Corporation
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
Asahi Kasei Pharma Corporation, Clinical Research Ethics Committee
Address
632-1 Mifuku, Izunokunishi, Shizuoka, Japan
Tel
0558-76-7029
takemura.mb@om.asahi-kasei.co.jp
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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Unpublished
Publication of results
Unpublished
Result
URL related to results and publications
Unpublished
Number of participants that the trial has enrolled
203
Results
Sensitivity, specificity and total concordance rate of the antigen kit with real-time PCR were 86.4%, 97.1% and 95.9% respectively.
Sensitivity, specificity and total concordance rate of the antigen kit with culture testing were 72.2%, 94.0% and 91.9% respectively.
Results date posted
| 2020 | Year | 09 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
203 patients suspected to be infected with Bordetella pertussis were enrolled.
Male 102, Female 101.
Age 0 - 69 years.
Participant flow
After informed consent was obtained, nasopharyngeal specimens were collected from 203 patients suspected to be infected with Bordetella pertussis and assayed by the antigen kit, real-time PCR and culture testing.
Adverse events
No adverse events were observed.
Outcome measures
Sensitivity, specificity and total concordance rate of the antigen kit with real-time PCR were 86.4%, 97.1% and 95.9% respectively.
Sensitivity, specificity and total concordance rate of the antigen kit with culture testing were 72.2%, 94.0% and 91.9% respectively.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
After informed consent was obtained, nasopharyngeal specimens were collected from patients suspected to be infected with Bordetella pertussis and assayed by the antigen kit, real-time PCR and culture testing.
Management information
Registered date
| 2020 | Year | 09 | Month | 17 | Day |
Last modified on
| 2020 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047749
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