Last updated: 06/26/2019 12:12:12

Pertussis infection in adolescents and adults with prolonged cough

GSK study ID
115741
Clinicaltrials.gov ID
NCT01597687
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Bordetella pertussis infection among adolescents and adults with prolonged cough
Trial description: 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.
Primary purpose:
Other
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Serological evidence of pertussis infection

Timeframe: At time of blood sampling (Day 0)

Secondary outcomes:

Number of Participants with Specific Clinical Features

Timeframe: 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

Timeframe: 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

Timeframe: At time of questionnaire administration (Day 0)

Assessment of Health Economical Impact - Number of visits to specific Healthcare Resources

Timeframe: At time of questionnaire administration (Day 0)

Assessment of health economical impact - Summary of travel costs for sero-confirmed subjects - Malaysia

Timeframe: At time of questionnaire administration (Day 0)

Assessment of health economical impact - Summary of travel costs for sero-confirmed subjects - Taiwan

Timeframe: At time of questionnaire administration (Day 0)

Assessment of health economical impact - Summary of travel costs for sero-confirmed subjects - Thailand

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: At time of questionnaire administration (Day 0)

Assessment of health economical impact - Summary of medical costs for sero-confirmed subjects visiting specialist clinics - Malaysia

Timeframe: At time of questionnaire administration (Day 0)

Assessment of health economical impact - Summary of medical costs for sero-confirmed subjects visiting specialist clinics - Taiwan

Timeframe: At time of questionnaire administration (Day 0)

Assessment of health economical impact - Summary of medical costs for sero-confirmed subjects visiting specialist clinics - Thailand

Timeframe: At time of questionnaire administration (Day 0)

Assessment of health economical impact - Summary of medical costs for sero-confirmed subjects visiting emergency rooms - Malaysia

Timeframe: At time of questionnaire administration (Day 0)

Assessment of health economical impact - Summary of medical costs for sero-confirmed subjects visiting emergency rooms - Taiwan

Timeframe: At time of questionnaire administration (Day 0)

Assessment of health economical impact - Summary of medical costs for sero-confirmed subjects visiting emergency rooms - Thailand

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: At time of questionnaire administration (Day 0)

Assessment of the impact of pertussis on quality of life of patients: Average EQ-5D index score

Timeframe: At time of questionnaire administration (Day 0)

Interventions:
Procedure/surgery: Blood collection
Other: Data collection
Enrollment:
337
Observational study model:
Not applicable
Primary completion date:
2013-02-05
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Pertussis
Product
GSK2647153A
Collaborators
Not applicable
Study date(s)
June 2012 to May 2013
Type
Interventional
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
13+ years
Accepts healthy volunteers
No
  • Adolescents aged 13-18 years or adults aged >18years.
  • Presenting with prolonged cough of 2 weeks (14 days) or more.
  • Child in care.
  • Subjects with known chronic cough-causing disease and immunodeficiency.
Inclusion and exclusion criteria
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).

Trial location(s)

Location
Status
Contact us
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Location
GSK Investigational Site
Bangkok, Thailand, 10400
Status
Study Complete
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Location
GSK Investigational Site
Khon Kaen, Thailand, 40002
Status
Study Complete
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Location
GSK Investigational Site
Kuala Lumpur, Malaysia, 59100
Status
Study Complete
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Location
GSK Investigational Site
Seremban, Malaysia, 70300
Status
Study Complete
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Location
GSK Investigational Site
Songkla, Thailand, 90110
Status
Study Complete
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Location
GSK Investigational Site
Taichung, Taiwan, 40447
Status
Study Complete
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Location
GSK Investigational Site
Taoyuan, Taiwan, 333
Status
Study Complete
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Study documents

No study documents available.

Results overview

Results posted on ClinicalTrials.gov

Recruitment status
Completed
Actual primary completion date
2013-02-05
Actual study completion date
2013-02-05

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Additional information
Not applicable
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