Streptococcus Pneumoniae CarriageNCT07562529
Whole Genome-Based Surveillance of Nasopharyngeal Pneumococcal Carriage in Vietnamese Children
An observational study of Streptococcus Pneumoniae Carriage and Pneumococcal Colonization, run by Phuc Huu Phan at 1 site in Vietnam.
Trial 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). Read more about this study
- Who is it for?
- Ages 2 months to 5 years
- Conditions the study is for
- Streptococcus Pneumoniae Carriage, Pneumococcal Colonization, Acute Respiratory Symptoms
- How many people
- 530 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Apr 2026to 30 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: Children aged 2 months to 59 months hospitalized at Vietnam National Children's Hospital with acute respiratory symptoms
Who may be able to join
- 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
Show all 11Show fewer
- Nasal obstruction
- Sore throat
- Tachypnea
- Wheeze
- Retraction
Who cannot join
- Confirmed pneumococcal infection within the past 30 days
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Whole Genome-Based Surveillance of Nasopharyngeal Pneumococcal Carriage and Serotype Distribution Among Vietnamese Children Hospitalized With Acute Respiratory Symptoms
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.
Read the 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.
- Keywords
- Pneumococcal carriage, Whole genome sequencing, Serotype distribution, PCV vaccine coverage, Vietnam, Pediatric surveillance
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Pneumococcal Carriage
Proportion of participants with S. pneumoniae detected from nasopharyngeal swab Analysis: Prevalence with 95% confidence intervals
Measured: At enrollment
Pneumococcal Serotype Distribution
Frequency distribution of pneumococcal serotypes identified via Whole Genome Sequencing
Measured: At enrollment
Secondary outcomes (2)
Antimicrobial Resistance Genes
Presence of resistance genes (e.g., ermB, mefA, pbp variants)
Measured: at enrollment
Vaccine Serotype Coverage
Proportion of identified serotypes covered by PCV10, PCV13, PCV15, PCV20
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start1 Apr 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Streptococcus Pneumoniae CarriageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 530 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Phuc Huu Phan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Phuc Huu Phan, National Children's Hospital, Vietnam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07562529
- Sponsor's protocol ID
- VNCH-TRICH-2026-50
- Status last verified
- Oct 2026
- First submitted
- 25 Apr 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD might be shared with relevant request and upon approval by local regulatory body
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole Genome-Based Surveillance of Nasopharyngeal Pneumococcal Carriage and Serotype Distribution Among Vietnamese Children Hospitalized With Acute Respiratory Symptoms
- ClinicalTrials.gov ID
- NCT07562529
- Acronym / sponsor ID
- VNCH-TRICH-2026-50
- Keywords
- Pneumococcal carriage, Whole genome sequencing, Serotype distribution, PCV vaccine coverage, Vietnam, Pediatric surveillance
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 530 participants (estimated)
- Lead sponsor
- Phuc Huu PhanUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged 2 months to 59 months hospitalized at Vietnam National Children's Hospital with acute respiratory symptoms
Key inclusion criteria (11 listed)
- Age 2 months to 59 months
- Hospitalized with acute respiratory symptoms (≤14 days duration)
- Parent or legal guardian provides written informed consent
- Cough
- Rhinorrhea
Key exclusion criteria (1 listed)
- Confirmed pneumococcal infection within the past 30 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of Pneumococcal Carriage
Time frame: At enrollment
Proportion of participants with S. pneumoniae detected from nasopharyngeal swab Analysis: Prevalence with 95% confidence intervals
Pneumococcal Serotype Distribution
Time frame: At enrollment
Frequency distribution of pneumococcal serotypes identified via Whole Genome Sequencing
2 secondary outcomes
Antimicrobial Resistance Genes
Time frame: at enrollment
Vaccine Serotype Coverage
Time frame: At enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: Undecided. IPD might be shared with relevant request and upon approval by local regulatory body
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Streptococcus Pneumoniae Carriage and Pneumococcal Colonization, run by Phuc Huu Phan at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Pneumococcal Carriage (time frame: At enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.