A Study on Pathogenic Surveillance and Nasopharyngeal Carriage of Children and Adolescents Based on Hospitals and Communities in Hainan Province

August 4, 2025 updated by: Wen-hong Zhang, Huashan Hospital
This study intends to screen children under the age of 10 for respiratory pathogens, Streptococcus pneumoniae, and serotyping in three representative cities in Hainan province: Haikou, Wanning, and Baisha, in order to provide a foundation for the subsequent promotion of Streptococcus pneumoniae vaccines.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this multi-center epidemiological study was to determine the carrier status of clinically diagnosed pneumonia, pathogen spectrum of clinically diagnosed pneumonia, serotype distribution, and drug resistance profile of Streptococcus pneumoniae in sick children from hospitals and healthy children from the community.

Study Type

Observational

Enrollment (Actual)

3746

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hainan
      • Baisha, Hainan, China
        • People's Hospital of Baisha Li Autonomous County
      • Haikou, Hainan, China
        • The First Affiliated Hospital of Hainan Medical University
      • Haikou, Hainan, China
        • Haikou Hospital of the Maternal and Child Health
      • Haikou, Hainan, China
        • Hainan Women and Childrens Medical Center
      • Wanning, Hainan, China
        • People's Hospital of Wanning

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

The prevalance of clinial diagnosed pneumonia and invasive diseases in Hainan Province will be mainly collected from the electronic medical record (EMR) database of selected hospitals and face-to-face questionnaire survey, in the fever clinics and pediatric wards of selected hospitals. A control group of healthy community children will be systematically sampled from residents from the same area as the cases and frequency-matched by age group.

Description

Inclusion Criteria:

  • 1. Case group: patients from fever clinics and pediatric wards

Patients with at least one of the following will be clinically diagnosed with pneumonia and recommended for NP/OP, blood cultures, or induced sputum as clinically indicated (TB only or if performed routinely by the clinician), bronchoalveolar lavage fluid (BALF , according to clinical requirements), pleural effusion (according to clinical requirements), and chest X-ray examination:

  1. Shortness of breath ( children <2 months, respiratory rate ≥60 breaths/min; children ≥2 months to <12 months, respiratory rate ≥50 breaths/min; children ≥12 months to < 60 months, respiratory rate ≥40 breaths/min; Children ≥ 60 months to < 120 months, respiratory rate > 24 breaths/minute )
  2. Rales on lung auscultation

  3. Respiratory symptoms and fever ( axillary temperature ≥ 37.5 ℃ or rectal temperature ≥ 38 ℃ )

    • 2. Control group The control group will be randomly selected from the community and frequency-matched 1:1 with the case group according to age group, sex and city.

Exclusion Criteria:

  • 1. Hospitalized within the first 14 days, or discharged as a case group within the first 30 days, and lived outside the research center area ;
  • 2. People who affect the research results: patients cannot keep samples or the amount of samples is not enough for testing;
  • 3. Can't cooperate well;
  • 4. The researcher judges that it is not suitable to be included in this study .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
case group
patients from fever clinics and pediatric wards
Diagnostic test: NP/OP swab
NP/OP (nasopharyngeal/oropharyngeal) swabs will be collected from all cases at enrollment for respiratory pathogen multiplex PCR or pneumococcus culture.
control group
healthy community children
Diagnostic test: NP/OP swab
NP/OP (nasopharyngeal/oropharyngeal) swabs will be collected from all cases at enrollment for respiratory pathogen multiplex PCR or pneumococcus culture.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of pneumococcus
Time Frame: 1 day
Estimate the prevalence of pneumococcus among children aged<10 years old hospitalized with clinical diagnosed pneumonia, in children seen at outpatient clinics, and among healthy children in the community in Hainan
1 day
Correaltion index of high load (>6.9 log10 copies/ml) pneumococcus
Time Frame: 1 day
Estimate the association with disease (i.e., case-control status) of high load (>6.9 log10 copies/ml) pneumococcus among outpatient or hospitalized patients with clinical diagnosed pneumonia in children aged<10 years old and among healthy children in the community in Hainan
1 day
Correaltion index of disease status of infection with different pathogens
Time Frame: 1 day
Estimate the association with disease status of infection with pathogens of interest (or combination of pathogens) among children aged<10 years old hospitalized with clinical diagnosed pneumonia compared to healthy children in the community in Hainan. The study is designed to be the case-control study
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimate the proportions of srotypes in patients and healthy children
Time Frame: 1 day
Estimate the pneumococcal serotype distribution in children aged<10 years old with clinically diagnosed pneumonia carrying pneumococcus in Hainan.
1 day
Describe the resistance proportion of antibiotics in different region in Hainan
Time Frame: 1 day
Describe the antimicrobial resistance patterns in children aged<10 years old with clinically diagnosed pneumonia carrying pneumococcus in Hainan.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huashan Hospital

Investigators

  • Principal Investigator: Wenhong Zhang, M.D., Huashan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2023

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

June 12, 2023

First Submitted That Met QC Criteria

June 12, 2023

First Posted (Actual)

June 22, 2023

Study Record Updates

Last Update Posted (Actual)

August 8, 2025

Last Update Submitted That Met QC Criteria

August 4, 2025

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HAPEC-Stage one 01&02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

After thesis defense the study may be published internationally to be available for the public.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pneumonia

Clinical Trials on NP/OP swab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Morocco

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe