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

Study Overview
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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.

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.

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

Conditions
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Pneumonia

Intervention / Treatment
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* Diagnostic Test: NP/OP swab


Participation Criteria
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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: 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 ) Rales on lung auscultation 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 .

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| case group<br>patients from fever clinics and pediatric wards | Diagnostic Test: NP/OP swab<br>* NP/OP (nasopharyngeal/oropharyngeal) swabs will be collected from all cases at enrollment for respiratory pathogen multiplex PCR or pneumococcus culture.<br>|
| control group<br>healthy community children | Diagnostic Test: NP/OP swab<br>* NP/OP (nasopharyngeal/oropharyngeal) swabs will be collected from all cases at enrollment for respiratory pathogen multiplex PCR or pneumococcus culture.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of pneumococcus | 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 | 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 | 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 | 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 | Describe the antimicrobial resistance patterns in children aged<10 years old with clinically diagnosed pneumonia carrying pneumococcus in Hainan. | 1 day |