Pertussis Infection in Adolescents and Adults With Prolonged Cough

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

337 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-20

Study Completion Date

2013-05-02

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pertussis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Malaysia Group

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

Group Type EXPERIMENTAL

Blood collection

Intervention Type PROCEDURE

1 blood sample will be collected from each subject.

Data collection

Intervention Type OTHER

Quality of Life and HE questionnaires.

Taiwan Group

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

Group Type EXPERIMENTAL

Blood collection

Intervention Type PROCEDURE

1 blood sample will be collected from each subject.

Data collection

Intervention Type OTHER

Quality of Life and HE questionnaires.

Thailand Group

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

Group Type EXPERIMENTAL

Blood collection

Intervention Type PROCEDURE

1 blood sample will be collected from each subject.

Data collection

Intervention Type OTHER

Quality of Life and HE questionnaires.

Interventions

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Blood collection

1 blood sample will be collected from each subject.

Intervention Type PROCEDURE

Data collection

Quality of Life and HE questionnaires.

Intervention Type OTHER

Eligibility Criteria

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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).

Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No