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Pneumococcal Carriage, Serotypes, and Antibiotic Resistance in Malaysian Children: A Multi-Centre Study

Recruitingn/aAges 0 Years - 5 YearsAllIMU University, Malaysia
NCT07545876 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this observational study is to determine the prevalence, serotype distribution, and antimicrobial resistance patterns of nasopharyngeal carriage of Streptococcus pneumoniae in Malaysian children aged ≤5 years following the implementation of pneumococcal conjugate vaccines (PCVs). The study focuses on healthy and mildly symptomatic male and female children aged 0-60 months recruited from urban and semi-urban settings in Kuala Lumpur, Selangor, and Negeri Sembilan. The main questions it aims to answer are: 1. What is the overall and age-specific prevalence of nasopharyngeal pneumococcal carriage among children aged ≤5 years in Malaysia? 2. What are the circulating serotypes and antimicrobial resistance (AMR) profiles of pneumococcal isolates, and how are they associated with vaccination status and PCV valency coverage? Researchers will compare carriage prevalence, serotype d

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📋 Eligibility rules (as published)
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
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What it tests

  • Not listed
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Where

4 sites
KMI Taman Desa Medical Centre
Kuala Lumpur, Malaysia
CMH Specialist Hospital
Seremban, Malaysia
Hospital Tuanku Jaafar
Seremban, Malaysia
Avisena Women's & Children Specialist Hospital
Shah Alam, Malaysia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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