Pertussis Infection in Adolescents and Adults With Prolonged Cough

Bordetella Pertussis Infection Among Adolescents and Adults With Prolonged Cough

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.

Study Overview

• Status: Completed
• Conditions: Pertussis
• Intervention / Treatment: Procedure: Blood collection; Other: Data collection

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.

• Study Type: Interventional
• Enrollment (Actual): 337
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Kuala Lumpur, Malaysia, 59100
    • GSK Investigational Site
  • Seremban, Malaysia, 70300
    • GSK Investigational Site
• Taiwan
  • Taichung, Taiwan, 40447
    • GSK Investigational Site
  • Taoyuan, Taiwan, 333
    • GSK Investigational Site
• Thailand
  • Bangkok, Thailand, 10400
    • GSK Investigational Site
  • Khon Kaen, Thailand, 40002
    • GSK Investigational Site
  • Songkla, Thailand, 90110
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Malaysia Group; Malaysian adults aged >19 years with prolonged cough of 2 weeks or more.	Procedure: Blood collection; 1 blood sample will be collected from each subject.; Other: Data collection; Quality of Life and HE questionnaires.
Experimental: Taiwan Group; Taiwanese adults aged >19 years with prolonged cough of 2 weeks or more.	Procedure: Blood collection; 1 blood sample will be collected from each subject.; Other: Data collection; Quality of Life and HE questionnaires.
Experimental: Thailand Group; Thailandese adults aged >19 years with prolonged cough of 2 weeks or more.	Procedure: Blood collection; 1 blood sample will be collected from each subject.; Other: Data collection; Quality of Life and HE questionnaires.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	At time of blood sampling (Day 0)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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).	At time of questionnaire administration (Day 0)
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.	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).	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)	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).	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).	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).	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).	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.	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.	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.	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.	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.	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.	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	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	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	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.	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.	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.	At time of questionnaire administration (Day 0)

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2012
• Primary Completion (Actual): May 2, 2013
• Study Completion (Actual): May 2, 2013

Study Registration Dates

• First Submitted: May 3, 2012
• First Submitted That Met QC Criteria: May 10, 2012
• First Posted (Estimate): May 14, 2012

Study Record Updates

• Last Update Posted (Actual): August 9, 2019
• Last Update Submitted That Met QC Criteria: June 25, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Prevalence; pertussis infection; health economic burden; prolonged cough
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Respiratory Tract Diseases; Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Whooping Cough
• Other Study ID Numbers: 115741

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO