GSK: Protocol Summary for 115741

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Protocol Summary for 115741

Protocol Summary
Protocol Id:	115741
Secondary Ids:
Title:	Bordetella pertussis infection among adolescents and adults with prolonged cough
Phase:	n\a
Acronym:
FDA Regulated Intervention?:	No
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?:	no
Study Type:	Interventional
Oversight Authority:	Philippines: Philippines Food and Drug Administration Malaysia: National Pharmaceutical Control Bureau Taiwan: Food and Drug Administration, Department of Health, Executive Yuan Thailand: Thai Food and Drug Administration
Collaborators:
Brief 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.
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.
Record Verification Date:	January 2013
Status:	Not yet recruiting
Why Study Stopped:
Study Start Date:	June 2012
Estimated Study Completion Date:	May 2013
Study Completion Date Type:	Anticipated
Estimated Primary Completion Date:	May 2013
Primary Completion Date Type:	Anticipated
Primary Purpose:	other
Allocation:	N\A
Masking:	Open Label
Masked Subject:	no
Masked Caregiver:	no
Masked Investigator:	no
Masked Assessor:	no
Study Design (Assignment):	Single Group Assignment
Study Classification (Endpoint):	N/A
Primary Outcomes:	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. During the study period (Approximately 1 year)
Secondary Outcomes:	Evaluation of clinical features of subjects, including paroxysm, whoop, night cough, cyanosis, fever and post-tussive vomiting. During the study period (Approximately 1 year) Assessment of health economical impact. During the study period (Approximately 1 year) Assessment of the impact of pertussis on quality of life of patients. During the study period (Approximately 1 year)
Conditions:	Diphtheria-Tetanus-acellular Pertussis Vaccines
Keywords:	pertussis infection Prevalence health economic burden prolonged cough
Eligibility Criteria:	Click to view inclusion/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).
Gender:	Both
Minimum Age:	13 Year
Maximum Age:
Enrollment:	770
Enrollment Type:	Anticipated
Healthy Volunteers?:	none
Central Contact:	Call Center
Central Contact Phone:	877-379-3718
Central Contact Email:	GSKClinicalSupportHD@gsk.com
Backup Central Contact:
Backup Central Contact Phone:
Backup Central Contact Email:
Overall Study Official:	GSK Clinical Trials
Overall Study Official Affiliation:	GlaxoSmithKline
Overall Study Official Role:	Study Director
Responsible Party Name/Official Title:	Cheri Hudson; Clinical Disclosure Advisor
Responsible Party Organization:	GSK Clinical Disclosure
Location and Contact Information:	Click to view location information Malaysia (click to view all sites in Malaysia) GSK Investigational Site Seremban, 70300; COMPLETED; Contact: Cheong Lieng Teng, Principal Investigator, . GSK Investigational Site Kuala Lumpur, 59100; COMPLETED; Contact: Mia Tuang Koh, Principal Investigator, . Taiwan (click to view all sites in Taiwan) GSK Investigational Site Taichung, 40447; RECRUITING; Contact: Chiu-Shong Liu, Principal Investigator, . GSK Investigational Site Taoyuan, 333; RECRUITING; Contact: Cheng-Hsun Chiu, Principal Investigator, . Thailand (click to view all sites in Thailand) GSK Investigational Site Bangkok, 10400; COMPLETED; Contact: Veerachai Watanaveeradej, Principal Investigator, . GSK Investigational Site Khon Kaen, 40002; COMPLETED; Contact: Watchara Boonsawat, Principal Investigator, . GSK Investigational Site Songkla, 90110; COMPLETED; Contact: Siwasak Juthong, Principal Investigator, .

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Protocol Summary for 115741