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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| case group | patients from fever clinics and pediatric wards |
| |
| control group | healthy community children |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NP/OP swab | Diagnostic Test | NP/OP (nasopharyngeal/oropharyngeal) swabs will be collected from all cases at enrollment for respiratory pathogen multiplex PCR or pneumococcus culture. |
| 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 |
| 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 |
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Inclusion Criteria:
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 ℃ )
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Wenhong Zhang, M.D. | Huashan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| People's Hospital of Baisha Li Autonomous County | Baisha | Hainan | China | |||
| Haikou Hospital of the Maternal and Child Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32601893 | Result | Alizadeh Chamkhaleh M, Esteghamati A, Sayyahfar S, Gandomi-Mohammadabadi A, Balasi J, Abdiaei H, Moradi Y, Moradi-Lakeh M. Serotype distribution of Streptococcus pneumoniae among healthy carriers and clinical patients: a systematic review from Iran. Eur J Clin Microbiol Infect Dis. 2020 Dec;39(12):2257-2267. doi: 10.1007/s10096-020-03963-z. Epub 2020 Jun 29. | |
| 31060951 |
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After thesis defense the study may be published internationally to be available for the public.
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| ID | Term |
|---|---|
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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Describe the antimicrobial resistance patterns in children aged<10 years old with clinically diagnosed pneumonia carrying pneumococcus in Hainan. |
| 1 day |
| Haikou |
| Hainan |
| China |
| Hainan Women and Childrens Medical Center | Haikou | Hainan | China |
| The First Affiliated Hospital of Hainan Medical University | Haikou | Hainan | China |
| People's Hospital of Wanning | Wanning | Hainan | China |
| Hocknell RE, Cleary DW, Srifeungfung S, Clarke SC. Serotype distribution of disease-causing Streptococcus pneumoniae in Thailand: A systematic review. Vaccine. 2019 May 27;37(24):3159-3166. doi: 10.1016/j.vaccine.2019.04.085. Epub 2019 May 3. |
| 22475858 | Result | Jauneikaite E, Jefferies JM, Hibberd ML, Clarke SC. Prevalence of Streptococcus pneumoniae serotypes causing invasive and non-invasive disease in South East Asia: a review. Vaccine. 2012 May 21;30(24):3503-14. doi: 10.1016/j.vaccine.2012.03.066. Epub 2012 Apr 1. |
| 34485957 | Result | Andrejko K, Ratnasiri B, Hausdorff WP, Laxminarayan R, Lewnard JA. Antimicrobial resistance in paediatric Streptococcus pneumoniae isolates amid global implementation of pneumococcal conjugate vaccines: a systematic review and meta-regression analysis. Lancet Microbe. 2021 Sep;2(9):e450-e460. doi: 10.1016/S2666-5247(21)00064-1. |
| 28745918 | Result | Lyu S, Hu HL, Yang YH, Yao KH. A systematic review about Streptococcus Pneumoniae serotype distribution in children in mainland of China before the PCV13 was licensed. Expert Rev Vaccines. 2017 Oct;16(10):997-1006. doi: 10.1080/14760584.2017.1360771. Epub 2017 Aug 9. |
| 24349263 | Result | Zhao C, Zhang F, Chu Y, Liu Y, Cao B, Chen M, Yu Y, Liao K, Zhang L, Sun Z, Hu B, Lei J, Hu Z, Zhang X, Wang H. Phenotypic and genotypic characteristic of invasive pneumococcal isolates from both children and adult patients from a multicenter surveillance in China 2005-2011. PLoS One. 2013 Dec 11;8(12):e82361. doi: 10.1371/journal.pone.0082361. eCollection 2013. |
| 35841380 | Result | DeVries A, McCauley K, Fadrosh D, Fujimura KE, Stern DA, Lynch SV, Vercelli D. Maternal prenatal immunity, neonatal trained immunity, and early airway microbiota shape childhood asthma development. Allergy. 2022 Dec;77(12):3617-3628. doi: 10.1111/all.15442. Epub 2022 Jul 25. |