Actively Recruiting
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
Eligibility Criteria
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
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
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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