Back to resultsPertussis Infection in Adolescents and Adults With Prolonged Cough
Primary Purpose
Pertussis
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Blood collection
Data collection
Sponsored by
About this trial
This is an interventional other trial for Pertussis focused on measuring pertussis infection, Prevalence, health economic burden, prolonged cough
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).
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Malaysia Group
Taiwan Group
Thailand Group
Arm Description
Malaysian adults aged >19 years with prolonged cough of 2 weeks or more.
Taiwanese adults aged >19 years with prolonged cough of 2 weeks or more.
Thailandese adults aged >19 years with prolonged cough of 2 weeks or more.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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.
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).
Assessment of Health Economical Impact - Number of Visits to Specific Healthcare Resources
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 - Malaysia
The travel costs were assessed in the local currency of each country, as follows: Malaysia - Malaysian ringgit (RM).
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)
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).
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).
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).
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).
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.
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.
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.
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.
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.
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.
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
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
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
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01597687
Brief Title
Pertussis Infection in Adolescents and Adults With Prolonged Cough
Official Title
Bordetella Pertussis Infection Among Adolescents and Adults With Prolonged Cough
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
June 20, 2012 (Actual)
Primary Completion Date
May 2, 2013 (Actual)
Study Completion Date
May 2, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pertussis
Keywords
pertussis infection, Prevalence, health economic burden, prolonged cough
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
337 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Malaysia Group
Arm Type
Experimental
Arm Description
Malaysian adults aged >19 years with prolonged cough of 2 weeks or more.
Arm Title
Taiwan Group
Arm Type
Experimental
Arm Description
Taiwanese adults aged >19 years with prolonged cough of 2 weeks or more.
Arm Title
Thailand Group
Arm Type
Experimental
Arm Description
Thailandese adults aged >19 years with prolonged cough of 2 weeks or more.
Intervention Type
Procedure
Intervention Name(s)
Blood collection
Intervention Description
1 blood sample will be collected from each subject.
Intervention Type
Other
Intervention Name(s)
Data collection
Intervention Description
Quality of Life and HE questionnaires.
Primary Outcome Measure Information:
Title
Serological Evidence of Pertussis Infection
Description
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)
Secondary Outcome Measure Information:
Title
Number of Participants With Specific Clinical Features
Description
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)
Title
Assessment of Health Economical Impact - Number of Days Absent From Work Due to Cough
Description
Absenteeism was assessed as the mean number of days missed from work due to cough.
Time Frame
At time of questionnaire administration (Day 0)
Title
Assessment of Health Economical Impact - Number of Sero-confirmed Subjects With Loss of Income Due to Missing Work
Description
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)
Title
Assessment of Health Economical Impact - Number of Visits to Specific Healthcare Resources
Description
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)
Title
Assessment of Health Economical Impact - Summary of Travel Costs for Sero-confirmed Subjects - Malaysia
Description
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)
Title
Assessment of Health Economical Impact - Summary of Travel Costs for Sero-confirmed Subjects - Taiwan
Description
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)
Title
Assessment of Health Economical Impact - Summary of Travel Costs for Sero-confirmed Subjects - Thailand
Description
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)
Title
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting the GP(s) - Malaysia
Description
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)
Title
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting the GP(s) - Taiwan
Description
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)
Title
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting the GP(s) - Thailand
Description
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)
Title
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Specialist Clinics - Malaysia
Description
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)
Title
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Specialist Clinics - Taiwan
Description
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)
Title
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Specialist Clinics - Thailand
Description
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)
Title
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Emergency Rooms - Malaysia
Description
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)
Title
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Emergency Rooms - Taiwan
Description
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)
Title
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Emergency Rooms - Thailand
Description
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)
Title
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Healthcare Resources in General - Malaysia
Description
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)
Title
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Healthcare Resources in General - Taiwan
Description
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)
Title
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Healthcare Resources in General - Thailand
Description
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)
Title
Assessment of Health Economical Impact - Summary of Total Amount of Time Spent by Sero-confirmed Subjects Visiting Healthcare Resources in General
Description
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)
Title
Assessment of the Impact of Pertussis on Quality of Life of Patients: Number of Participants Reporting Problems With Specific Characteristics
Description
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)
Title
Assessment of the Impact of Pertussis on Quality of Life of Patients: Average EQ-5D Index Score
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
GSK Investigational Site
City
Seremban
ZIP/Postal Code
70300
Country
Malaysia
Facility Name
GSK Investigational Site
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
GSK Investigational Site
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
GSK Investigational Site
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
GSK Investigational Site
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
GSK Investigational Site
City
Songkla
ZIP/Postal Code
90110
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26468043
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.
Results Reference
derived
Learn more about this trial
Pertussis Infection in Adolescents and Adults With Prolonged Cough
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