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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05912010
Enrollment
3746
Registered
2023-06-22
Start date
2023-04-24
Completion date
2024-12-31
Last updated
2025-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumonia

Brief summary

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.

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.

Interventions

DIAGNOSTIC_TESTNP/OP swab

NP/OP (nasopharyngeal/oropharyngeal) swabs will be collected from all cases at enrollment for respiratory pathogen multiplex PCR or pneumococcus culture.

Sponsors

Huashan Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Months to 10 Years
Healthy volunteers
Yes

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 .

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of pneumococcus1 dayEstimate 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
Correaltion index of high load (>6.9 log10 copies/ml) pneumococcus1 dayEstimate 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
Correaltion index of disease status of infection with different pathogens1 dayEstimate 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

Secondary

MeasureTime frameDescription
Estimate the proportions of srotypes in patients and healthy children1 dayEstimate the pneumococcal serotype distribution in children aged\<10 years old with clinically diagnosed pneumonia carrying pneumococcus in Hainan.
Describe the resistance proportion of antibiotics in different region in Hainan1 dayDescribe the antimicrobial resistance patterns in children aged\<10 years old with clinically diagnosed pneumonia carrying pneumococcus in Hainan.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026