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RECRUITING
NCT07545876

Pneumococcal Carriage, Serotypes, and Antibiotic Resistance in Malaysian Children: A Multi-Centre Study

Sponsor: IMU University, Malaysia

View on ClinicalTrials.gov

Summary

The goal of this observational study is to determine the prevalence, serotype distribution, and antimicrobial resistance patterns of nasopharyngeal carriage of Streptococcus pneumoniae in Malaysian children aged ≤5 years following the implementation of pneumococcal conjugate vaccines (PCVs). The study focuses on healthy and mildly symptomatic male and female children aged 0-60 months recruited from urban and semi-urban settings in Kuala Lumpur, Selangor, and Negeri Sembilan. The main questions it aims to answer are: 1. What is the overall and age-specific prevalence of nasopharyngeal pneumococcal carriage among children aged ≤5 years in Malaysia? 2. What are the circulating serotypes and antimicrobial resistance (AMR) profiles of pneumococcal isolates, and how are they associated with vaccination status and PCV valency coverage? Researchers will compare carriage prevalence, serotype distribution (vaccine-type vs non-vaccine-type), and antimicrobial resistance patterns across different states, vaccination statuses, and socioeconomic backgrounds to determine differences in transmission dynamics and potential serotype replacement patterns. Participants will: 1. Undergo a nasopharyngeal swab collection for pneumococcal detection. 2. Provide demographic and vaccination history information through a standardised case report form completed with parental/guardian consent. 3. Have their samples analysed using bacterial culture, antimicrobial susceptibility testing, and whole-genome sequencing (WGS) for serotyping and resistance profiling.

Official title: Nasopharyngeal Carriage, Serotype Distribution, and Antimicrobial Resistance Profile of Streptococcus Pneumoniae in Malaysian Children: A Prospective Multi-Centre Study

Key Details

Gender

All

Age Range

0 Years - 5 Years

Study Type

OBSERVATIONAL

Enrollment

600

Start Date

2026-04-09

Completion Date

2027-06-30

Last Updated

2026-06-09

Healthy Volunteers

Yes

Locations (4)

KMI Taman Desa Medical Centre

Kuala Lumpur, Kuala Lumpur, Malaysia

CMH Specialist Hospital

Seremban, Negeri Sembilan, Malaysia

Hospital Tuanku Jaafar

Seremban, Negeri Sembilan, Malaysia

Avisena Women's & Children Specialist Hospital

Shah Alam, Selangor, Malaysia