Clinical study to evaluate the Bordetella pertussis antigen kit for patients suspected to be infected with Bordetella pertussis

Clinical study to evaluate the Bordetella pertussis antigen kit for patients suspected to be infected with Bordetella pertussis - Clinical study to evaluate the Bordetella pertussis antigen kit for patients suspected to be infected with Bordetella pertussis

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000041828

Enrollment

130

Registered

2020-10-01

Start date

2016-12-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Whooping cough

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

Exclusion criteria: 1. Patients who refuse to collect nasopharyngeal swabs. 2. Patients who doctors judge to be inappropriate to participate in the study.

Design outcomes

Primary

Measure	Time frame
Correlative evaluation of the antigen kit with each result of real-time PCR assay and culture testing.	—

Countries

Japan

Contacts

Public ContactTooru Hayakawa

Asahi Kasei Pharma Corporation Diagnostics dept

hayakawa.th@om.asahi-kasei.co.jp03-6699-3617

Outcome results