Pertussis Infection in Adolescents and Adults With Prolonged Cough
This study is not yet open for participant recruitment.
Verified May 2013 by GlaxoSmithKline
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01597687
First received: May 3, 2012
Last updated: May 30, 2013
Last verified: May 2013
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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 |
|---|---|
|
Diphtheria-Tetanus-acellular Pertussis Vaccines |
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 ]
| Estimated Enrollment: | 770 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | May 2013 |
| Estimated 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
Contacts
| Contact: US GSK Clinical Trials Call Center | 877-379-3718 | GSKClinicalSupportHD@gsk.com |
Locations
| Malaysia | |
| GSK Investigational Site | Completed |
| Kuala Lumpur, Malaysia, 59100 | |
| GSK Investigational Site | Completed |
| Seremban, Malaysia, 70300 | |
| Taiwan | |
| GSK Investigational Site | Completed |
| Taichung, Taiwan, 40447 | |
| GSK Investigational Site | Completed |
| Taoyuan, Taiwan, 333 | |
| Thailand | |
| GSK Investigational Site | Completed |
| Bangkok, Thailand, 10400 | |
| GSK Investigational Site | Completed |
| Khon Kaen, Thailand, 40002 | |
| GSK Investigational Site | Completed |
| 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: | May 30, 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:
|
Diphtheria Whooping Cough Tetanus Corynebacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections |
Bordetella Infections Gram-Negative Bacterial Infections Respiratory Tract Infections Infection Respiratory Tract Diseases Clostridium Infections |
ClinicalTrials.gov processed this record on June 17, 2013