Pertussis Infection in Adolescents and Adults With Prolonged Cough

Not Applicable

Completed

Conditions: Pertussis

Interventions: Procedure: Blood collection
Other: Data collection

Registration Number: NCT01597687

Lead Sponsor: GlaxoSmithKline

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 337

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).

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Malaysia Group	Data collection	Malaysian adults aged \>19 years with prolonged cough of 2 weeks or more.
Taiwan Group	Data collection	Taiwanese adults aged \>19 years with prolonged cough of 2 weeks or more.
Malaysia Group	Blood collection	Malaysian adults aged \>19 years with prolonged cough of 2 weeks or more.
Taiwan Group	Blood collection	Taiwanese adults aged \>19 years with prolonged cough of 2 weeks or more.
Thailand Group	Data collection	Thailandese adults aged \>19 years with prolonged cough of 2 weeks or more.
Thailand Group	Blood collection	Thailandese adults aged \>19 years with prolonged cough of 2 weeks or more.

Primary Outcome Measures

Name	Time	Method
Serological Evidence of Pertussis Infection	At time of blood sampling (Day 0)	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

Secondary Outcome Measures

Name	Time	Method
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Healthcare Resources in General - Taiwan	At time of questionnaire administration (Day 0)	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
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting the GP(s) - Malaysia	At time of questionnaire administration (Day 0)	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).
Number of Participants With Specific Clinical Features	At time of clinical data collection prior to enrolment (Day 0)	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.
Assessment of Health Economical Impact - Summary of Travel Costs for Sero-confirmed Subjects - Malaysia	At time of questionnaire administration (Day 0)	The travel costs were assessed in the local currency of each country, as follows: Malaysia - Malaysian ringgit (RM).
Assessment of Health Economical Impact - Number of Days Absent From Work Due to Cough	At time of questionnaire administration (Day 0)	Absenteeism was assessed as the mean number of days missed from work due to cough.
Assessment of Health Economical Impact - Number of Sero-confirmed Subjects With Loss of Income Due to Missing Work	At time of questionnaire administration (Day 0)	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).
Assessment of Health Economical Impact - Number of Visits to Specific Healthcare Resources	At time of questionnaire administration (Day 0)	Healthcare resource utilization was assessed by the mean number of visits to any type of physicians.
Assessment of Health Economical Impact - Summary of Travel Costs for Sero-confirmed Subjects - Taiwan	At time of questionnaire administration (Day 0)	The travel costs were assessed in the local currency of each country, as follows: Taiwan - New Taiwan dollar (NTD)
Assessment of Health Economical Impact - Summary of Total Amount of Time Spent by Sero-confirmed Subjects Visiting Healthcare Resources in General	At time of questionnaire administration (Day 0)	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.
Assessment of Health Economical Impact - Summary of Travel Costs for Sero-confirmed Subjects - Thailand	At time of questionnaire administration (Day 0)	The travel costs were assessed in the local currency of each country, as follows: Thailand - Thai baht (BAHT).
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting the GP(s) - Taiwan	At time of questionnaire administration (Day 0)	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).
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting the GP(s) - Thailand	At time of questionnaire administration (Day 0)	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).
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Specialist Clinics - Malaysia	At time of questionnaire administration (Day 0)	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.
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Specialist Clinics - Taiwan	At time of questionnaire administration (Day 0)	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.
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Emergency Rooms - Malaysia	At time of questionnaire administration (Day 0)	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.
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Emergency Rooms - Thailand	At time of questionnaire administration (Day 0)	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.
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Healthcare Resources in General - Malaysia	At time of questionnaire administration (Day 0)	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
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Specialist Clinics - Thailand	At time of questionnaire administration (Day 0)	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.
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Emergency Rooms - Taiwan	At time of questionnaire administration (Day 0)	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.
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Healthcare Resources in General - Thailand	At time of questionnaire administration (Day 0)	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
Assessment of the Impact of Pertussis on Quality of Life of Patients: Number of Participants Reporting Problems With Specific Characteristics	At time of questionnaire administration (Day 0)	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.
Assessment of the Impact of Pertussis on Quality of Life of Patients: Average EQ-5D Index Score	At time of questionnaire administration (Day 0)	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.