Pertussis Infection in Adolescents and Adults With Prolonged Cough

Pertussis Clinical Trial

Official title:

Bordetella Pertussis Infection Among Adolescents and Adults With Prolonged Cough

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01597687
• Other study ID #: 115741
• Status: Completed
• Phase: N/A
• Start date: June 20, 2012
• Est. completion date: May 2, 2013

Study information

• Verified date: June 2019
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 337
• Est. completion date: May 2, 2013
• Est. primary completion date: May 2, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Infection
• Pertussis
• Whooping Cough

Intervention

Procedure:
• Blood collection
1 blood sample will be collected from each subject.

Other:
• Data collection
Quality of Life and HE questionnaires.

Locations

Country	Name	City	State
Malaysia	GSK Investigational Site	Kuala Lumpur
Malaysia	GSK Investigational Site	Seremban
Taiwan	GSK Investigational Site	Taichung
Taiwan	GSK Investigational Site	Taoyuan
Thailand	GSK Investigational Site	Bangkok
Thailand	GSK Investigational Site	Khon Kaen
Thailand	GSK Investigational Site	Songkla

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Malaysia,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)