Pertussis Infection in Adolescents and Adults With Prolonged Cough

Study Overview
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Brief Summary
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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
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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.

Official Title
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Bordetella Pertussis Infection Among Adolescents and Adults With Prolonged Cough

Conditions
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Pertussis

Intervention / Treatment
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* Procedure: Blood collection
* Other: Data collection


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pertussis infection, Prevalence, health economic burden, prolonged cough