Whole Genome-Based Surveillance of Nasopharyngeal Pneumococcal Carriage in Vietnamese Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Streptococcus Pneumoniae Carriage, Pneumococcal Colonization, Acute Respiratory Symptoms. Basic parameters: 2 months — 5 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Vietnam
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Whole Genome-Based Surveillance of Nasopharyngeal Pneumococcal Carriage and Serotype Distribution Among Vietnamese Children Hospitalized With Acute Respiratory Symptoms
Overview
This hospital-based cross-sectional study aims to determine the prevalence and serotype distribution of nasopharyngeal Streptococcus pneumoniae carriage among children aged 2-59 months hospitalized with acute respiratory symptoms at Vietnam National Children's Hospital (VNCH). Whole genome sequencing (WGS) will be used for serotype identification, antimicrobial resistance gene detection, and characterization of co-colonization patterns. The study will compare carriage prevalence and serotype distribution between previously healthy children and children with underlying comorbidities. Findings will inform pneumococcal vaccine policy and antimicrobial resistance surveillance in Vietnam.
Detailed description
Nasopharyngeal colonization with Streptococcus pneumoniae is a prerequisite for invasive pneumococcal disease. In Vietnam, PCV10 and PCV13 have been introduced in the private sector; however, updated surveillance data reflecting post-vaccine serotype dynamics are limited.
This study will enroll 530 children aged 2 months to 59 months hospitalized with acute respiratory symptoms. Participants will be categorized into:
* Group 1: Previously healthy children * Group 2: Children with chronic underlying conditions Nasopharyngeal swabs will be collected at enrollment. Streptococcus pneumoniae isolates will undergo culture, identification using MALDI-TOF MS, and whole genome sequencing using the Illumina NextSeq platform. Bioinformatic analysis will include in silico serotyping, MLST typing, resistance gene detection, and co-colonization assessment.
The study will evaluate associations between pneumococcal carriage and demographic, clinical, vaccination, and environmental factors.
Primary outcome measures
- Prevalence of Pneumococcal Carriage [Time frame: At enrollment]
- Pneumococcal Serotype Distribution [Time frame: At enrollment]
Secondary outcome measures (2)
- Antimicrobial Resistance Genes [Time frame: at enrollment]
- Vaccine Serotype Coverage [Time frame: At enrollment]
Eligibility criteria
Inclusion criteria
- Age 2 months to 59 months
- Hospitalized with acute respiratory symptoms (≤14 days duration)
- Parent or legal guardian provides written informed consent
Acute respiratory symptoms defined as one or more of:
- Cough
- Rhinorrhea
- Nasal obstruction
- Sore throat
- Tachypnea
- Wheeze
- Retraction
Exclusion criteria
- Confirmed pneumococcal infection within the past 30 days
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Vietnam · 1 center
- Vietnam National Children's Hospital — Hanoi
Identifiers
NCT: NCT07562529 · VNCH-TRICH-2026-50