Pneumococcus carriage and antibiotic resistance in Malaysian children under 5
Nasopharyngeal Carriage, Serotype Distribution, and Antimicrobial Resistance Profile of Streptococcus Pneumoniae in Malaysian Children: A Prospective Multi-Centre Study
We'll test how often children under 5 in Malaysia carry pneumococcus in their nose, which serotypes they have, and whether those bacteria resist common antibiotics after the national vaccine rollout.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 0 Years to 5 Years |
| Sex | All |
| Sponsor | IMU University, Malaysia Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 4 sites (Kuala Lumpur, Kuala Lumpur and 3 other locations) |
| Trial ID | NCT07545876 on ClinicalTrials.gov |
What this trial studies
This observational cross-sectional effort will collect nasopharyngeal swabs from healthy and mildly symptomatic children aged 0–60 months at three urban and semi-urban centers in Kuala Lumpur, Selangor, and Negeri Sembilan. Samples will be cultured, serotyped, and subjected to antimicrobial susceptibility testing to determine carriage prevalence, circulating serotypes, and resistance patterns. Researchers will compare carriage rates and serotype/antibiotic-resistance profiles by age group and by vaccination history, including exposure to PCV10 and PCV13. The work aims to track serotype replacement and inform local vaccine and antibiotic policy decisions.
Who should consider this trial
Good fit: Healthy or mildly symptomatic children aged 0–60 months who have lived in Malaysia at least 3 months, are hemodynamically stable, have not used antibiotics in the past 30 days, and whose parent or guardian can give written consent.
Not a fit: Children who recently used antibiotics, have known immunodeficiency or recent chemotherapy/transplant, are on high‑dose steroids, have had nasal surgery, or live outside the recruitment areas are unlikely to be eligible or to benefit from this protocol.
Why it matters
Potential benefit: If successful, the results could help tailor vaccine strategy and antibiotic guidelines to better prevent and treat pneumococcal disease in Malaysian children.
How similar studies have performed: Similar nasopharyngeal carriage and serotype surveillance studies worldwide have successfully tracked serotype shifts and antimicrobial resistance after PCV introduction, but post‑NIP data from Malaysia remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Kuala Lumpur, Kuala Lumpur and 3 other locations
- KMI Taman Desa Medical Centre — Kuala Lumpur, Kuala Lumpur, Malaysia (Recruiting)
- CMH Specialist Hospital — Seremban, Negeri Sembilan, Malaysia (Recruiting)
- Hospital Tuanku Jaafar — Seremban, Negeri Sembilan, Malaysia (Recruiting)
- Avisena Women's & Children Specialist Hospital — Shah Alam, Selangor, Malaysia (Recruiting)
Study contacts
- Principal investigator: Nurul Hanis Ramzi — IMU University, Malaysia
- Study coordinator: Nurul Hanis Ramzi
- Email: nurulhanis@imu.edu.my
- Phone: +60173396532
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.