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

NCT07545876 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2026-06-09

No results posted yet for this study

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.

Conditions

  • Nasopharyngeal Carriage of Streptococcus Pneumoniae

Sponsors & Collaborators

  • IMU University, Malaysia

    lead OTHER

Principal Investigators

  • Nurul Hanis Ramzi · IMU University, Malaysia

Eligibility

Min Age
0 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-09
Primary Completion
2027-04-30
Completion
2027-06-30

Countries

  • Malaysia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07545876 on ClinicalTrials.gov