Clinical trial NCT01597687: Pertussis Infection in Adolescents and Adults With Prolonged Cough
Official title: Bordetella Pertussis Infection Among Adolescents and Adults With Prolonged Cough
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pertussis
Keywords: pertussis infection
Prevalence
health economic burden
prolonged cough
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-05-14
Enrollment: 337
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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).

Primary outcomes:
measure: Serological Evidence of Pertussis Infection
timeFrame: At time of blood sampling (Day 0)
Secondary outcomes:
measure: Number of Participants With Specific Clinical Features
timeFrame: At time of clinical data collection prior to enrolment (Day 0)
measure: Assessment of Health Economical Impact - Number of Days Absent From Work Due to Cough
timeFrame: At time of questionnaire administration (Day 0)
measure: Assessment of Health Economical Impact - Number of Sero-confirmed Subjects With Loss of Income Due to Missing Work
timeFrame: At time of questionnaire administration (Day 0)
measure: Assessment of Health Economical Impact - Number of Visits to Specific Healthcare Resources
timeFrame: At time of questionnaire administration (Day 0)
measure: Assessment of Health Economical Impact - Summary of Travel Costs for Sero-confirmed Subjects - Malaysia
timeFrame: At time of questionnaire administration (Day 0)
measure: Assessment of Health Economical Impact - Summary of Travel Costs for Sero-confirmed Subjects - Taiwan
timeFrame: At time of questionnaire administration (Day 0)
measure: Assessment of Health Economical Impact - Summary of Travel Costs for Sero-confirmed Subjects - Thailand
timeFrame: At time of questionnaire administration (Day 0)
measure: Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting the GP(s) - Malaysia
timeFrame: At time of questionnaire administration (Day 0)
measure: Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting the GP(s) - Taiwan
timeFrame: At time of questionnaire administration (Day 0)
measure: Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting the GP(s) - Thailand
timeFrame: At time of questionnaire administration (Day 0)
measure: Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Specialist Clinics - Malaysia
timeFrame: At time of questionnaire administration (Day 0)
measure: Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Specialist Clinics - Taiwan
timeFrame: At time of questionnaire administration (Day 0)
measure: Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Specialist Clinics - Thailand
timeFrame: At time of questionnaire administration (Day 0)
measure: Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Emergency Rooms - Malaysia
timeFrame: At time of questionnaire administration (Day 0)
measure: Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Emergency Rooms - Taiwan
timeFrame: At time of questionnaire administration (Day 0)
measure: Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Emergency Rooms - Thailand
timeFrame: At time of questionnaire administration (Day 0)
measure: Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Healthcare Resources in General - Malaysia
timeFrame: At time of questionnaire administration (Day 0)
measure: Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Healthcare Resources in General - Taiwan
timeFrame: At time of questionnaire administration (Day 0)
measure: Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Healthcare Resources in General - Thailand
timeFrame: At time of questionnaire administration (Day 0)
measure: Assessment of Health Economical Impact - Summary of Total Amount of Time Spent by Sero-confirmed Subjects Visiting Healthcare Resources in General
timeFrame: At time of questionnaire administration (Day 0)
measure: Assessment of the Impact of Pertussis on Quality of Life of Patients: Number of Participants Reporting Problems With Specific Characteristics
timeFrame: At time of questionnaire administration (Day 0)
measure: Assessment of the Impact of Pertussis on Quality of Life of Patients: Average EQ-5D Index Score
timeFrame: At time of questionnaire administration (Day 0)
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: GSK Investigational Site
city: Seremban
country: Malaysia
facility: GSK Investigational Site
city: Taichung
country: Taiwan
facility: GSK Investigational Site
city: Taoyuan
country: Taiwan
facility: GSK Investigational Site
city: Bangkok
country: Thailand
facility: GSK Investigational Site
city: Khon Kaen
country: Thailand
facility: GSK Investigational Site
city: Songkla
country: Thailand
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Koh MT, Liu CS, Chiu CH, Boonsawat W, Watanaveeradej V, Abdullah N, Zhang X, Devadiga R, Chen J. Under-recognized pertussis in adults from Asian countries: a cross-sectional seroprevalence study in Malaysia, Taiwan and Thailand. Epidemiol Infect. 2016 Apr;144(6):1192-200. doi: 10.1017/S0950268815002393. Epub 2015 Oct 15.