Whole Genome-Based Surveillance of Nasopharyngeal Pneumoc... | NCT07562529

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

NCT07562529

Sponsor

Phuc Huu Phan

Status

Enrolling by invitation

Last Update Posted

May 1, 2026Actual

Enrollment

530Estimated

Phase

Not provided

Conditions

Streptococcus Pneumoniae Carriage
Pneumococcal Colonization
Acute Respiratory Symptoms

Interventions

Not provided

Countries

Vietnam

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2026Actual

Primary Completion Date

Jun 30, 2027Estimated

Completion Date

Sep 30, 2027Estimated

First Submitted Date

Apr 25, 2026

First Submission Date that Met QC Criteria

Apr 25, 2026

First Posted Date

May 1, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 25, 2026

Last Update Posted Date

May 1, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

530Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevalence of Pneumococcal Carriage	Proportion of participants with S. pneumoniae detected from nasopharyngeal swab Analysis: Prevalence with 95% confidence intervals	At enrollment
Pneumococcal Serotype Distribution	Frequency distribution of pneumococcal serotypes identified via Whole Genome Sequencing	At enrollment

Secondary Outcomes

Measure	Description	Time Frame
Antimicrobial Resistance Genes	Presence of resistance genes (e.g., ermB, mefA, pbp variants)	at enrollment
Vaccine Serotype Coverage	Proportion of identified serotypes covered by PCV10, PCV13, PCV15, PCV20

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Months

Maximum Age

5 Years

Standard Ages

Child

Study Population

Children aged 2 months to 59 months hospitalized at Vietnam National Children's Hospital with acute respiratory symptoms

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vietnam National Children's Hospital		Hanoi		00000	Vietnam

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

IPD might be shared with relevant request and upon approval by local regulatory body

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided