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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3746 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-24

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pneumonia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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case group

patients from fever clinics and pediatric wards

NP/OP swab

Intervention Type DIAGNOSTIC_TEST

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

NP/OP swab

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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NP/OP swab

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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 .

Minimum Eligible Age

1 Month

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes