Pertussis Infection in Adolescents and Adults With Prolonged Cough

NCT01597687 | Completed Results

• 1 other identifier: 115741
• Study Type: interventional
• Target: 337
• Locations: 3 countries
• Sites: 7

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.

Conditions

Pertussis

Keywords

pertussis infection; Prevalence; health economic burden; prolonged cough

Outcome Measures

Primary Outcomes (1)

• Serological Evidence of Pertussis Infection

  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

  At time of blood sampling (Day 0)

Secondary Outcomes (22)

• Number of Participants With Specific Clinical Features

  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

  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

  At time of questionnaire administration (Day 0)

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

  At time of questionnaire administration (Day 0)

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

  At time of questionnaire administration (Day 0)

Study Arms (3)

Malaysia Group

EXPERIMENTAL

Malaysian adults aged \>19 years with prolonged cough of 2 weeks or more.

Procedure: Blood collection; Other: Data collection

Taiwan Group

EXPERIMENTAL

Taiwanese adults aged \>19 years with prolonged cough of 2 weeks or more.

Procedure: Blood collection; Other: Data collection

Thailand Group

EXPERIMENTAL

Thailandese adults aged \>19 years with prolonged cough of 2 weeks or more.

Procedure: Blood collection; Other: Data collection

Interventions

Blood collection PROCEDURE

1 blood sample will be collected from each subject.

Malaysia Group; Taiwan Group; Thailand Group

Data collection OTHER

Quality of Life and HE questionnaires.

Malaysia Group; Taiwan Group; Thailand Group

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (7)

GSK Investigational Site

Kuala Lumpur, 59100, Malaysia

Location

GSK Investigational Site

Seremban, 70300, Malaysia

Location

GSK Investigational Site

Taichung, 40447, Taiwan

Location

GSK Investigational Site

Taoyuan District, 333, Taiwan

Location

GSK Investigational Site

Bangkok, 10400, Thailand

Location

GSK Investigational Site

Khon Kaen, 40002, Thailand

Location

GSK Investigational Site

Songkhla, 90110, Thailand

Location

Related Publications (1)

• Koh MT, Liu CS, Chiu CH, Boonsawat W, Watanaveeradej V, Abdullah N, Zhang X, Devadiga R, Chen J. Under-recognized pertussis in adults from Asian countries: a cross-sectional seroprevalence study in Malaysia, Taiwan and Thailand. Epidemiol Infect. 2016 Apr;144(6):1192-200. doi: 10.1017/S0950268815002393. Epub 2015 Oct 15.

  PMID: 26468043 DERIVED

MeSH Terms

Conditions

Whooping Cough

Interventions

Blood Specimen Collection; Data Collection

Condition Hierarchy (Ancestors)

Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2012
• First Posted: May 14, 2012
• Study Start: June 20, 2012
• Primary Completion: May 2, 2013
• Study Completion: May 2, 2013
• Last Updated: August 9, 2019
• Results First Posted: August 9, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

MY (2); TW (2); TH (3)