Whole Genome-Based Surveillance of Nasopharyngeal Pneumococcal Carriage and Serotype Distribution Among Vietnamese Children Hospitalized With Acute Respiratory Symptoms
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 530
- 试验地点
- 1
- 主要终点
- Prevalence of Pneumococcal Carriage
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •Rhinorrhea
- •Nasal obstruction
- •Sore throat
- •Tachypnea
- •Retraction
排除标准
- •Confirmed pneumococcal infection within the past 30 days
结局指标
主要结局
Prevalence of Pneumococcal Carriage
时间窗: At enrollment
Proportion of participants with S. pneumoniae detected from nasopharyngeal swab Analysis: Prevalence with 95% confidence intervals
Pneumococcal Serotype Distribution
时间窗: At enrollment
Frequency distribution of pneumococcal serotypes identified via Whole Genome Sequencing
次要结局
- Antimicrobial Resistance Genes(at enrollment)
- Vaccine Serotype Coverage(At enrollment)
研究者
Phuc Huu Phan
Dr.
National Children's Hospital, Vietnam