RecruitingNCT07545876

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

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


Sponsor

IMU University, Malaysia

Enrollment

600 participants

Start Date

Apr 9, 2026

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 0 YearsMax Age: 5 Years

Inclusion Criteria4

  • Children aged ≤5 years (0-60 months)
  • Hemodynamically stable at the time of sampling
  • Parent/guardian provides written informed consent
  • Resident in Malaysia for at least 3 months prior to enrolment

Exclusion Criteria4

  • Current or recent antibiotic use within the last 30 days
  • Known to have an immunodeficiency or currently on chemotherapy, or post-transplant recipients or on high-dose steroids (defined as >20mg/day or 2mg/kg/day of Prednisolone for 2 weeks or more)
  • Has nasal surgery
  • Refusal of consent by parent or guardian

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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

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NCT07545876