Pertussis Infection in Adolescents and Adults With Prolonged Cough

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Pertussis

Treatments: Other: Data collection; Procedure: Blood collection

Study type: Interventional

Funder types: Industry

Identifiers

NCT01597687

115741

Details and patient eligibility

About

This study aims to determine the burden of pertussis infection among adolescents and adults with prolonged cough in four Asian countries, namely Malaysia, Philippines, Taiwan and Thailand. This study also aims to assess the health economic (HE) impact of pertussis.

Full description

Data from this cross-sectional study will be useful in reviewing the need for introduction of booster doses of pertussis vaccines in adolescent and adult population in Malaysia, Philippines, Taiwan and Thailand.

This study will enrol patients with prolonged cough of 2 weeks or more and detect pertussis with serological tests in order to estimate the prevalence of pertussis infection among such patients. No vaccine will be administered during this study.

Enrollment: 337 patients

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adolescents aged 13-18 years or adults aged >18years.
• Presenting with prolonged cough of 2 weeks (14 days) or more.
• Subjects who the investigator believes that they/ their parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol.
• Written informed consent obtained from the subject/ from the parent(s)/LAR of the subject. If the subject below the age of consent is legally eligible, his/her signature on the informed assent form should be obtained.

Exclusion criteria

• Child in care.
• Subjects with known chronic cough-causing disease and immunodeficiency.
• Subjects treated with angiotensin-converting enzyme inhibitors (ACEI), within the past 4 weeks (28 days).

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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337 participants in 3 patient groups

Malaysia Group

Experimental group

Description:

Malaysian adults aged \>19 years with prolonged cough of 2 weeks or more.

Treatment:

Other: Data collection

Procedure: Blood collection

Taiwan Group

Experimental group

Description:

Taiwanese adults aged \>19 years with prolonged cough of 2 weeks or more.

Treatment:

Other: Data collection

Procedure: Blood collection

Thailand Group

Experimental group

Description:

Thailandese adults aged \>19 years with prolonged cough of 2 weeks or more.

Treatment:

Other: Data collection

Procedure: Blood collection