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.
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
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
337
1 blood sample will be collected from each subject.
Quality of Life and HE questionnaires.
GSK Investigational Site
Kuala Lumpur, Malaysia
GSK Investigational Site
Seremban, Malaysia
GSK Investigational Site
Taichung, Taiwan
GSK Investigational Site
Taoyuan, Taiwan
Serological Evidence of Pertussis Infection
Serological evidence of pertussis infection was defined as anti-pertussis toxin (PT) immunoglobulin G (IgG) level indicative of active or recent infection. The parameters presented were defined as follows: Seropositive = Subjects with anti-PT IgG ELISA levels ≥10 IU/ml , Seronegative = Subjects with anti-PT IgG ELISA levels \< 10 IU/ml , Sero-confirmed infection = Subjects with anti-PT IgG ELISA levels ≥62.5 IU/ml , Active infection 1= Anti-PT IgG ELISA levels ≥ 100 IU/ml indicative of active or recent infection, Active infection 2 = Anti-PT IgG ELISA levels ≥ 125 IU/ml indicative of active or recent infection
Time frame: At time of blood sampling (Day 0)
Number of Participants With Specific Clinical Features
Clinical features assessed included paroxysm, whoop, night cough, cyanosis, fever post-tussive vomiting, apnoea, cyanosis, coughing up phlegm, sneezes, wheezes, episodes of being unable to stop coughing and breathlessness/chest pain.
Time frame: At time of clinical data collection prior to enrolment (Day 0)
Assessment of Health Economical Impact - Number of Days Absent From Work Due to Cough
Absenteeism was assessed as the mean number of days missed from work due to cough.
Time frame: At time of questionnaire administration (Day 0)
Assessment of Health Economical Impact - Number of Sero-confirmed Subjects With Loss of Income Due to Missing Work
Loss of income due to missing work for sero-confirmed subjects was measured in the local currency of each country, as follows: Malaysia - Malaysian ringgit (RM), Taiwan - New Taiwan dollar (NTD), Thailand - Thai baht (BAHT).
Time frame: At time of questionnaire administration (Day 0)
Assessment of Health Economical Impact - Number of Visits to Specific Healthcare Resources
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GSK Investigational Site
Bangkok, Thailand
GSK Investigational Site
Khon Kaen, Thailand
GSK Investigational Site
Songkhla, Thailand
Healthcare resource utilization was assessed by the mean number of visits to any type of physicians.
Time frame: At time of questionnaire administration (Day 0)
Assessment of Health Economical Impact - Summary of Travel Costs for Sero-confirmed Subjects - Malaysia
The travel costs were assessed in the local currency of each country, as follows: Malaysia - Malaysian ringgit (RM).
Time frame: At time of questionnaire administration (Day 0)
Assessment of Health Economical Impact - Summary of Travel Costs for Sero-confirmed Subjects - Taiwan
The travel costs were assessed in the local currency of each country, as follows: Taiwan - New Taiwan dollar (NTD)
Time frame: At time of questionnaire administration (Day 0)
Assessment of Health Economical Impact - Summary of Travel Costs for Sero-confirmed Subjects - Thailand
The travel costs were assessed in the local currency of each country, as follows: Thailand - Thai baht (BAHT).
Time frame: At time of questionnaire administration (Day 0)
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting the GP(s) - Malaysia
The medical costs were assessed in the local currency of each country, as follows: Malaysia - Malaysian ringgit (RM). Total medical cost included the cost spent for consultation, medicines, laboratory tests etc., for visiting the GP(s).
Time frame: At time of questionnaire administration (Day 0)
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting the GP(s) - Taiwan
The medical costs were assessed in the local currency of each country, as follows: Taiwan - New Taiwan dollar (NTD). Total medical cost included the cost spent for consultation, medicines, laboratory tests etc., for visiting the GP(s).
Time frame: At time of questionnaire administration (Day 0)
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting the GP(s) - Thailand
The medical costs were assessed in the local currency of each country, as follows: Thailand - Thai baht (BAHT). Total medical cost included the cost spent for consultation, medicines, laboratory tests etc., for visiting the GP(s).
Time frame: At time of questionnaire administration (Day 0)
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Specialist Clinics - Malaysia
The medical costs were assessed in the local currency of each country, as follows: Malaysia - Malaysian ringgit (RM). Total medical cost included the cost spent for consultation, medicines, laboratory tests etc., for visiting the specialist clinics.
Time frame: At time of questionnaire administration (Day 0)
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Specialist Clinics - Taiwan
The medical costs were assessed in the local currency of each country, as follows: Taiwan - New Taiwan dollar (NTD). Total medical cost included the cost spent for consultation, medicines, laboratory tests etc., for visiting the specialist clinics.
Time frame: At time of questionnaire administration (Day 0)
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Specialist Clinics - Thailand
The medical costs were assessed in the local currency of each country, as follows: Thailand - Thai baht (BAHT). Total medical cost included the cost spent for consultation, medicines, laboratory tests etc., for visiting the specialist clinics.
Time frame: At time of questionnaire administration (Day 0)
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Emergency Rooms - Malaysia
The medical costs were assessed in the local currency of each country, as follows: Malaysia - Malaysian ringgit (RM). Total medical cost included the cost spent for consultation, medicines, laboratory tests etc., for visiting the emergency rooms.
Time frame: At time of questionnaire administration (Day 0)
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Emergency Rooms - Taiwan
The medical costs were assessed in the local currency of each country, as follows: Taiwan - New Taiwan dollar (NTD). Total medical cost included the cost spent for consultation, medicines, laboratory tests etc., for visiting the emergency rooms.
Time frame: At time of questionnaire administration (Day 0)
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Emergency Rooms - Thailand
The medical costs were assessed in the local currency of each country, as follows: Thailand - Thai baht (BAHT). Total medical cost included the cost spent for consultation, medicines, laboratory tests etc., for visiting the emergency rooms.
Time frame: At time of questionnaire administration (Day 0)
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Healthcare Resources in General - Malaysia
The medical costs were assessed in the local currency of each country, as follows: Malaysia - Malaysian ringgit (RM). Total medical cost included the cost spent for consultation, medicines, laboratory tests etc., for visiting the healthcare resources in general
Time frame: At time of questionnaire administration (Day 0)
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Healthcare Resources in General - Taiwan
The medical costs were assessed in the local currency of each country, as follows: Taiwan - New Taiwan dollar (NTD). Total medical cost included the cost spent for consultation, medicines, laboratory tests etc., for visiting the healthcare resources in general
Time frame: At time of questionnaire administration (Day 0)
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Healthcare Resources in General - Thailand
The medical costs were assessed in the local currency of each country, as follows: Thailand - Thai baht (BAHT). Total medical cost included the cost spent for consultation, medicines, laboratory tests etc., for visiting the healthcare resources in general
Time frame: At time of questionnaire administration (Day 0)
Assessment of Health Economical Impact - Summary of Total Amount of Time Spent by Sero-confirmed Subjects Visiting Healthcare Resources in General
Total amount of time spent on seeing the doctor(s) which includes the return trip and the overall time spent at clinic(s)/hospital(s) for waiting, consultation, tests, pharmacy etc.
Time frame: At time of questionnaire administration (Day 0)
Assessment of the Impact of Pertussis on Quality of Life of Patients: Number of Participants Reporting Problems With Specific Characteristics
Health-related quality of life of pertussis patients was assessed using the EQ-5D Questionnaire. The EQ-5D is composed of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), with 3 levels of severity within each dimension. The EQ-5D levels were further dichotomised into "no problems" (level 1) and "with problems" (level 2 \& 3). The number of participants within these 2 levels are reported.
Time frame: At time of questionnaire administration (Day 0)
Assessment of the Impact of Pertussis on Quality of Life of Patients: Average EQ-5D Index Score
Health-related quality of life of pertussis patients was assessed using the EQ-5D Questionnaire. The EQ-5D is composed of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), with 3 levels of severity within each dimension. Average of EQ-5D index score (ranging from 0 to 1; 0 being death and 1 being in perfect health) across sero-confirmed participants was reported.
Time frame: At time of questionnaire administration (Day 0)