N/A N=312 Other

Pertussis Infection in Adolescents and Adults With Prolonged Cough

Pertussis

Bottom Line

View on ClinicalTrials.gov: NCT01597687 ↗

Enrolled (actual)

312

Serious AEs

0.0%

Results posted

Aug 2019

Primary outcome: Primary: Serological Evidence of Pertussis Infection — 50; 74; 84; 26 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Blood collection (Procedure); Data collection (Other)
Age: Pediatric, Adult, Older Adult · 13+ yrs
Sex: All
Sponsor: GlaxoSmithKline
Primary completion: May 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Serological Evidence of Pertussis Infection	50; 74; 84; 26; 15; 63	—
SECONDARY Number of Participants With Specific Clinical Features	2; 18; 14; 278; 12; 143	—
SECONDARY Assessment of Health Economical Impact - Number of Days Absent From Work Due to Cough	7.75; 0.00; 0.22; 0.25; 0.00; 0.22	—
SECONDARY Assessment of Health Economical Impact - Number of Sero-confirmed Subjects With Loss of Income Due to Missing Work	1; 0; 0; 3; 1; 9	—
SECONDARY Assessment of Health Economical Impact - Number of Visits to Specific Healthcare Resources	3.17; 0.00; 1.00; 0.33; 8.00; 1.00	—
SECONDARY Assessment of Health Economical Impact - Summary of Travel Costs for Sero-confirmed Subjects - Malaysia	43.83; 2.50; 9.17; 55.50	—
SECONDARY Assessment of Health Economical Impact - Summary of Travel Costs for Sero-confirmed Subjects - Taiwan	0.00; 2400.00; 300.00; 2700.00	—
SECONDARY Assessment of Health Economical Impact - Summary of Travel Costs for Sero-confirmed Subjects - Thailand	1133.30; 668.89; 0.00; 1802.20	—
SECONDARY Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting the GP(s) - Malaysia	47.50; 43.33	—
SECONDARY Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting the GP(s) - Taiwan	0.00; 0.00	—
SECONDARY Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting the GP(s) - Thailand	1114.30; 1114.30	—
SECONDARY Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Specialist Clinics - Malaysia	0.00; 0.00	—
SECONDARY Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Specialist Clinics - Taiwan	1700.00; 1700.00	—
SECONDARY Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Specialist Clinics - Thailand	645.71; 645.71	—
SECONDARY Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Emergency Rooms - Malaysia	0.00; 0.00	—
SECONDARY Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Emergency Rooms - Taiwan	750.00; 750.00	—
SECONDARY Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Emergency Rooms - Thailand	0.00; 0.00	—
SECONDARY Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Healthcare Resources in General - Malaysia	47.50; 43.33	—
SECONDARY Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Healthcare Resources in General - Taiwan	2450.00; 2450.00	—
SECONDARY Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Healthcare Resources in General - Thailand	1760.00; 1760.00	—
SECONDARY Assessment of Health Economical Impact - Summary of Total Amount of Time Spent by Sero-confirmed Subjects Visiting Healthcare Resources in General	6.38; 0.00; 2.28; 0.33; 20.00; 2.97	—
SECONDARY Assessment of the Impact of Pertussis on Quality of Life of Patients: Number of Participants Reporting Problems With Specific Characteristics	6; 1; 7; 0; 0; 2	—
SECONDARY Assessment of the Impact of Pertussis on Quality of Life of Patients: Average EQ-5D Index Score	0.84; 0.66; 0.75	—

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.

Eligibility 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).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01597687). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.