Bordetella Pertussis Infection Among Adolescents and Adults With Prolonged Cough
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 337
- 试验地点
- 8
- 主要终点
- Serological Evidence of Pertussis Infection
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Taiwan Group
Taiwanese adults aged >19 years with prolonged cough of 2 weeks or more.
干预措施: Blood collection (Procedure)
Taiwan Group
Taiwanese adults aged >19 years with prolonged cough of 2 weeks or more.
干预措施: Data collection (Other)
Thailand Group
Thailandese adults aged >19 years with prolonged cough of 2 weeks or more.
干预措施: Blood collection (Procedure)
Thailand Group
Thailandese adults aged >19 years with prolonged cough of 2 weeks or more.
干预措施: Data collection (Other)
Malaysia Group
Malaysian adults aged >19 years with prolonged cough of 2 weeks or more.
干预措施: Data collection (Other)
Malaysia Group
Malaysian adults aged >19 years with prolonged cough of 2 weeks or more.
干预措施: Blood collection (Procedure)
结局指标
主要结局
Serological Evidence of Pertussis Infection
时间窗: 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
次要结局
- 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))
- 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))
- Number of Participants With Specific Clinical Features(At time of clinical data collection prior to enrolment (Day 0))
- Assessment of Health Economical Impact - Summary of Travel Costs for Sero-confirmed Subjects - Malaysia(At time of questionnaire administration (Day 0))
- Assessment of Health Economical Impact - Number of Days Absent 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(At time of questionnaire administration (Day 0))
- Assessment of Health Economical Impact - Number of Visits to Specific Healthcare Resources(At time of questionnaire administration (Day 0))
- Assessment of Health Economical Impact - Summary of Travel Costs for Sero-confirmed Subjects - Taiwan(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(At time of questionnaire administration (Day 0))
- Assessment of Health Economical Impact - Summary of Travel Costs for Sero-confirmed Subjects - Thailand(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(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(At time of questionnaire administration (Day 0))
- Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Specialist Clinics - Malaysia(At time of questionnaire administration (Day 0))
- Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Specialist Clinics - Taiwan(At time of questionnaire administration (Day 0))
- Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Emergency Rooms - Malaysia(At time of questionnaire administration (Day 0))
- Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Emergency Rooms - Thailand(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(At time of questionnaire administration (Day 0))
- Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Specialist Clinics - Thailand(At time of questionnaire administration (Day 0))
- Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Emergency Rooms - Taiwan(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(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(At time of questionnaire administration (Day 0))
- Assessment of the Impact of Pertussis on Quality of Life of Patients: Average EQ-5D Index Score(At time of questionnaire administration (Day 0))