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OpenTrials
Enrolling by Invitation

NCT Number: NCT07562529

Whole Genome-Based Surveillance of Nasopharyngeal Pneumococcal Carriage in Vietnamese Children

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.

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Key information

Age range

2 month–5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Vietnam National Children's Hospital

Hanoi, 00000, Vietnam

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Prevalence of Pneumococcal Carriage

    Time frame: At enrollment

    Proportion of participants with S. pneumoniae detected from nasopharyngeal swab Analysis: Prevalence with 95% confidence intervals

  2. Pneumococcal Serotype Distribution

    Time frame: At enrollment

    Frequency distribution of pneumococcal serotypes identified via Whole Genome Sequencing

Secondary outcomes

  1. Antimicrobial Resistance Genes

    Time frame: at enrollment

    Presence of resistance genes (e.g., ermB, mefA, pbp variants)

  2. Vaccine Serotype Coverage

    Time frame: At enrollment

    Proportion of identified serotypes covered by PCV10, PCV13, PCV15, PCV20

Sponsors and collaborators

Lead sponsor

Phuc Huu Phan

Other

Registry information

Official study title

Whole Genome-Based Surveillance of Nasopharyngeal Pneumococcal Carriage and Serotype Distribution Among Vietnamese Children Hospitalized With Acute Respiratory Symptoms

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 1, 2026
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.