Actively Recruiting

Age: 0Years - 5Years
All Genders
Healthy Volunteers
NCT07545876

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

Led by IMU University, Malaysia · Updated on 2026-04-22

600

Participants Needed

4

Research Sites

63 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 0Years - 5Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 5 years or younger (0-60 months)
  • Hemodynamically stable at the time of sampling
  • Parent or guardian provides written informed consent
  • Resident in Malaysia for at least 3 months prior to enrollment
Not Eligible

You will not qualify if you...

  • Current or recent antibiotic use within the last 30 days
  • Known immunodeficiency, chemotherapy, post-transplant, or high-dose steroid use (over 20mg/day or 2mg/kg/day of Prednisolone for 2 weeks or more)
  • History of nasal surgery
  • Parent or guardian refuses consent

AI-Screening

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Trial Site Locations

Total: 4 locations

1

KMI Taman Desa Medical Centre

Kuala Lumpur, Kuala Lumpur, Malaysia, 58100

Actively Recruiting

2

CMH Specialist Hospital

Seremban, Negeri Sembilan, Malaysia, 70200

Actively Recruiting

3

Hospital Tuanku Jaafar

Seremban, Negeri Sembilan, Malaysia, 70300

Actively Recruiting

4

Avisena Women's & Children Specialist Hospital

Shah Alam, Selangor, Malaysia, 40000

Actively Recruiting

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Research Team

N

Nurul Hanis Ramzi

CONTACT

E

Erwin Khoo Jiayuan

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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