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Completed

NCT Number: NCT01597687

Pertussis Infection in 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.

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Key information

Conditions

Pertussis Bacterial Infections Bacterial Infections and Mycoses Bordetella Infections Gram-Negative Bacterial Infections Infections Respiratory Tract Diseases Respiratory Tract Infections Whooping Cough

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GSK Investigational Site, Kuala Lumpur, Malaysia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Blood Collection

Procedure

1 blood sample will be collected from each subject.

Data Collection

Other

Quality of Life and HE questionnaires.

Primary outcomes

  1. Serological Evidence of Pertussis Infection

    Time frame: 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

Secondary outcomes

  1. Number of Participants With Specific Clinical Features

    Time frame: At time of clinical data collection prior to enrolment (Day 0)

    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.

  2. Assessment of Health Economical Impact - Number of Days Absent From Work Due to Cough

    Time frame: At time of questionnaire administration (Day 0)

    Absenteeism was assessed as the mean number of days missed from work due to cough.

  3. Assessment of Health Economical Impact - Number of Sero-confirmed Subjects With Loss of Income Due to Missing Work

    Time frame: At time of questionnaire administration (Day 0)

    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).

  4. Assessment of Health Economical Impact - Number of Visits to Specific Healthcare Resources

    Time frame: At time of questionnaire administration (Day 0)

    Healthcare resource utilization was assessed by the mean number of visits to any type of physicians.

  5. Assessment of Health Economical Impact - Summary of Travel Costs for Sero-confirmed Subjects - Malaysia

    Time frame: At time of questionnaire administration (Day 0)

    The travel costs were assessed in the local currency of each country, as follows: Malaysia - Malaysian ringgit (RM).

  6. Assessment of Health Economical Impact - Summary of Travel Costs for Sero-confirmed Subjects - Taiwan

    Time frame: At time of questionnaire administration (Day 0)

    The travel costs were assessed in the local currency of each country, as follows: Taiwan - New Taiwan dollar (NTD)

  7. Assessment of Health Economical Impact - Summary of Travel Costs for Sero-confirmed Subjects - Thailand

    Time frame: At time of questionnaire administration (Day 0)

    The travel costs were assessed in the local currency of each country, as follows: Thailand - Thai baht (BAHT).

  8. Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting the GP(s) - Malaysia

    Time frame: At time of questionnaire administration (Day 0)

    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).

  9. Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting the GP(s) - Taiwan

    Time frame: At time of questionnaire administration (Day 0)

    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).

  10. Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting the GP(s) - Thailand

    Time frame: At time of questionnaire administration (Day 0)

    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).

  11. Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Specialist Clinics - Malaysia

    Time frame: At time of questionnaire administration (Day 0)

    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.

  12. Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Specialist Clinics - Taiwan

    Time frame: At time of questionnaire administration (Day 0)

    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.

  13. Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Specialist Clinics - Thailand

    Time frame: At time of questionnaire administration (Day 0)

    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.

  14. Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Emergency Rooms - Malaysia

    Time frame: At time of questionnaire administration (Day 0)

    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.

  15. Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Emergency Rooms - Taiwan

    Time frame: At time of questionnaire administration (Day 0)

    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.

  16. Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Emergency Rooms - Thailand

    Time frame: At time of questionnaire administration (Day 0)

    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.

  17. Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Healthcare Resources in General - Malaysia

    Time frame: At time of questionnaire administration (Day 0)

    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

  18. Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Healthcare Resources in General - Taiwan

    Time frame: At time of questionnaire administration (Day 0)

    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

  19. Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Healthcare Resources in General - Thailand

    Time frame: At time of questionnaire administration (Day 0)

    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

  20. Assessment of Health Economical Impact - Summary of Total Amount of Time Spent by Sero-confirmed Subjects Visiting Healthcare Resources in General

    Time frame: At time of questionnaire administration (Day 0)

    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.

  21. Assessment of the Impact of Pertussis on Quality of Life of Patients: Number of Participants Reporting Problems With Specific Characteristics

    Time frame: At time of questionnaire administration (Day 0)

    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.

  22. Assessment of the Impact of Pertussis on Quality of Life of Patients: Average EQ-5D Index Score

    Time frame: At time of questionnaire administration (Day 0)

    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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Bordetella Pertussis Infection Among Adolescents and Adults With Prolonged Cough

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 14, 2012
Registry last updated
Aug 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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