Understanding pneumococcal carriage in children with ear infections in Malaysia
Pneumococcal Carriage and Serotype Distribution in Children With Otitis Media in Malaysia.
This study is trying to see how common certain bacteria are in children with ear infections in Malaysia to understand the impact of vaccines and antibiotic resistance.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 360 (estimated) |
| Ages | 3 Months to 5 Years |
| Sex | All |
| Sponsor | International Medical University Academic / other |
| Locations | 2 sites (Kuantan, Pahang and 1 other locations) |
| Trial ID | NCT05429541 on ClinicalTrials.gov |
What this trial studies
This observational study aims to conduct a multi-center surveillance of pneumococcal carriage and serotype distribution in children diagnosed with otitis media (OM) in Malaysia. It will gather crucial baseline data to assess the long-term impacts of pneumococcal conjugate vaccines (PCV10 and PCV13) on the epidemiology of OM. The study will also evaluate changes in antibiotic resistance among the pneumococcal strains identified. By establishing sentinel surveillance, the research seeks to provide detailed insights into the burden of OM in Malaysia and contribute to the development of a national monitoring program.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 3 months to under 5 years with clinically diagnosed acute otitis media or chronic suppurative otitis media.
Not a fit: Patients who have had nasal surgery, chronic respiratory diseases, cardiac conditions, or tympanostomy tubes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of pneumococcal infections in children, leading to improved vaccination strategies and management of otitis media.
How similar studies have performed: Other studies have shown success in similar approaches to understanding pneumococcal epidemiology, making this study a valuable addition to existing research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Children aged ≥3 months and \<5 years with clinically diagnosed AOM/CSOM whose parent/legal authorized representative (LAR) is willing to give consent on his/her behalf and attending general practitioner clinics, the ear, nose and throat (ENT) outpatient's department or admitted as a hospital inpatient at hospital sites. Exclusion Criteria: Any child aged ≥3 months and \<5 years old * who does not meet the case definition * whose parent/guardian does not give consent on his/her behalf. * who had nasal surgery, * who has chronic respiratory diseases (including asthma) and cardiac condition * with tympanostomy tubes
Where this trial is running
Kuantan, Pahang and 1 other locations
- Sultan Ahmad Shah Medical Centre @International Islamic University Malaysia — Kuantan, Pahang, Malaysia (Recruiting)
- Universiti Putra Malaysia — Serdang, Seri Kembangan, Malaysia (Recruiting)
Study contacts
- Principal investigator: Lokman Hakim Sulaiman, PhD — International Medical University
- Study coordinator: Nur Alia Johari, PhD
- Email: NurAliaJohari@imu.edu.my
- Phone: +60 12 234 5651
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.