Clinical Trial: Pertussis Infection in Adolescents and Adults With Prolonged Cough
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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 Summary:
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.
Sponsor: GlaxoSmithKline
Current Primary Outcome: Serological evidence of pertussis infection among adolescents aged 13-18 years and adults aged >18 years, defined as anti-pertussis toxin (PT) IgG level indicative of active or recent infection. [ Time Frame: During the study period (Approximately 1 year) ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Evaluation of clinical features of subjects, including paroxysm, whoop, night cough, cyanosis, fever and post-tussive vomiting. [ Time Frame: During the study period (Approximately 1 year) ]
- Assessment of health economical impact. [ Time Frame: During the study period (Approximately 1 year) ]
- Assessment of the impact of pertussis on quality of life of patients. [ Time Frame: During the study period (Approximately 1 year) ]
Original Secondary Outcome: Same as current
Information By: GlaxoSmithKline
Dates:
Date Received: May 3, 2012
Date Started: June 2012
Date Completion:
Last Updated: November 7, 2013
Last Verified: November 2013
