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Search / Trial NCT05429541

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

Launched by INTERNATIONAL MEDICAL UNIVERSITY · Jun 19, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying how common a bacteria called Streptococcus pneumoniae is in children with ear infections, known as otitis media, in Malaysia. The researchers want to understand which types of this bacteria are present and how they might be changing over time, especially after the introduction of different vaccines. This information will help us learn more about the impact of vaccines on ear infections and antibiotic resistance, which is when bacteria become harder to treat with medicines.

To participate, children aged 3 months to under 5 years who have been diagnosed with an ear infection and whose parents agree to take part can be included. However, children with certain conditions, like those who have had nasal surgery or have chronic respiratory or heart issues, cannot join. If eligible, participants will be asked to visit clinics or hospitals where their health will be monitored, contributing to a larger effort to improve understanding and treatment of ear infections in Malaysia.

Gender

ALL

Eligibility 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

About International Medical University

The International Medical University (IMU) is a prestigious educational institution dedicated to advancing healthcare through innovative research and clinical education. As a leading sponsor of clinical trials, IMU is committed to enhancing medical knowledge and improving patient outcomes by facilitating rigorous scientific studies across various medical disciplines. With a focus on ethical practices and collaboration with healthcare professionals, IMU aims to contribute to the development of effective therapies and interventions, ensuring that its research aligns with global health priorities and regulatory standards.

Locations

Kuantan, Pahang, Malaysia

Serdang, Seri Kembangan, Malaysia

Patients applied

0 patients applied

Trial Officials

Lokman Hakim Sulaiman, PhD

Principal Investigator

International Medical University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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