UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000041828
Receipt No. 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 (Ver. 1)

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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
Email 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
Email hayakawa.th@om.asahi-kasei.co.jp

Sponsor
Institute Asahi Kasei Pharma Corporation
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047749