Pneumococcal Carriage and Serotype Distribution in Children With Otitis Media in Malaysia.

NCT05429541 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 360

Last updated 2023-08-07

No results posted yet for this study

Summary

The purpose of this research is to conduct a multi-center prospective surveillance study focusing upon pneumococcal carriage and serotype epidemiology in patients with otitis media (OM).The data generated will be crucial especially as baseline data for future assessments on the long-term impacts of pneumococcal conjugate vaccine 10 (PCV10) coverage, compared to that of pneumococcal conjugate vaccine 13 (PCV13) that is being used in the majority of other countries. Pneumococcal carriage in patients with OM and serotype distribution will be assessed, including changes in antibiotic resistance. With the establishment of sentinel surveillance in the country, we hope to provide detailed data on the epidemiology of OM in Malaysia; working towards the development of a national surveillance programme for the monitoring of OM burden in the country.

Conditions

  • Streptococcus Pneumonia
  • Otitis Media

Sponsors & Collaborators

  • International Islamic University Malaysia

    collaborator OTHER
  • Universiti Putra Malaysia

    collaborator OTHER
  • University of Southampton

    collaborator OTHER
  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY
  • Hospital Serdang

    collaborator UNKNOWN
  • IMU University, Malaysia

    lead OTHER

Principal Investigators

  • Lokman Hakim Sulaiman, PhD · IMU University, Malaysia

Eligibility

Min Age
3 Months
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-05
Primary Completion
2024-04-05
Completion
2025-09-30

Countries

  • Malaysia

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05429541 on ClinicalTrials.gov