Brief Title
Pertussis Infection in Adolescents and Adults With Prolonged Cough
Official Title
Bordetella Pertussis Infection Among Adolescents and Adults With Prolonged Cough
Brief Summary
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.
Detailed 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.
Study Type
Interventional
Primary Outcome
Serological Evidence of Pertussis Infection
Secondary Outcome
Number of Participants With Specific Clinical Features
Condition
Pertussis
Intervention
Blood collection
Study Arms / Comparison Groups
Malaysia Group
Description: Malaysian adults aged >19 years with prolonged cough of 2 weeks or more.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
337
Start Date
June 20, 2012
Completion Date
May 2, 2013
Primary Completion Date
May 2, 2013
Eligibility Criteria
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).
Gender
All
Ages
13 Years - N/A
Accepts Healthy Volunteers
No
Contacts
GSK Clinical Trials, ,
Location Countries
Malaysia
Location Countries
Malaysia
Administrative Informations
NCT ID
NCT01597687
Organization ID
115741
Responsible Party
Sponsor
Study Sponsor
GlaxoSmithKline
Study Sponsor
GSK Clinical Trials, Study Director, GlaxoSmithKline
Verification Date
June 2019