Pertussis Infection in Adolescents and Adults With Prolonged Cough

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01597687
First received: May 3, 2012
Last updated: November 7, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Pertussis
Procedure: Blood collection
Other: Data collection

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Bordetella Pertussis Infection Among Adolescents and Adults With Prolonged Cough

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Serological evidence of pertussis infection among adolescents aged 13-18 years and adults aged >18 years, defined as anti-pertussis toxin (PT) IgG level indicative of active or recent infection. [ Time Frame: During the study period (Approximately 1 year) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of clinical features of subjects, including paroxysm, whoop, night cough, cyanosis, fever and post-tussive vomiting. [ Time Frame: During the study period (Approximately 1 year) ] [ Designated as safety issue: No ]
  • Assessment of health economical impact. [ Time Frame: During the study period (Approximately 1 year) ] [ Designated as safety issue: No ]
  • Assessment of the impact of pertussis on quality of life of patients. [ Time Frame: During the study period (Approximately 1 year) ] [ Designated as safety issue: No ]

Enrollment: 337
Study Start Date: June 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group A
Adolescents aged 13-18 years and adults aged >18 years with prolonged cough of 2 weeks or more.
Procedure: Blood collection
1 blood sample will be collected from each subject.
Other: Data collection
Quality of Life and HE questionnaires.

Detailed 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.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01597687

Locations
Malaysia
GSK Investigational Site
Kuala Lumpur, Malaysia, 59100
GSK Investigational Site
Seremban, Malaysia, 70300
Taiwan
GSK Investigational Site
Taichung, Taiwan, 40447
GSK Investigational Site
Taoyuan, Taiwan, 333
Thailand
GSK Investigational Site
Bangkok, Thailand, 10400
GSK Investigational Site
Khon Kaen, Thailand, 40002
GSK Investigational Site
Songkla, Thailand, 90110
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01597687     History of Changes
Other Study ID Numbers: 115741
Study First Received: May 3, 2012
Last Updated: November 7, 2013
Health Authority: Philippines: Philippines Food and Drug Administration
Taiwan: Food and Drug Administration, Department of Health, Executive Yuan
Thailand: Thai Food and Drug Administration
Malaysia: National Pharmaceutical Control Bureau

Keywords provided by GlaxoSmithKline:
pertussis infection
Prevalence
health economic burden
prolonged cough

Additional relevant MeSH terms:
Whooping Cough
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 21, 2014