Pneumococcus carriage and antibiotic resistance in Malaysian children under 5
Official title: Nasopharyngeal Carriage, Serotype Distribution, and Antimicrobial Resistance Profile of Streptococcus Pneumoniae in Malaysian Children: A Prospective Multi-Centre Study
Run by IMU University, Malaysia · NCT07545876 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 0 Years to 5 Years |
| Sex | All |
| Enrollment | 600 (estimated) |
| Sponsor | IMU University, Malaysia Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 4 sites (Kuala Lumpur, Kuala Lumpur and 3 other locations) |
| Status | Recruiting |
| Started | April 9, 2026 |
| Main results expected | April 30, 2027 |
| Study ends | June 30, 2027 |
| Registry record updated | June 9, 2026 |
| Trial ID | NCT07545876 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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 take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.