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

NCT05912010 | Completed

• 1 other identifier: HAPEC-Stage one 01&02
• Study Type: observational
• Target: 3,746
• Locations: 1 country
• Sites: 5

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.

Conditions

Pneumonia

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Estimate the proportions of srotypes in patients and healthy children

  1 day

• Describe the resistance proportion of antibiotics in different region in Hainan

  1 day

Study Arms (2)

case group

patients from fever clinics and pediatric wards

Diagnostic Test: NP/OP swab

control group

healthy community children

Diagnostic Test: NP/OP swab

Interventions

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.

case group; control group

Eligibility Criteria

• Age: 1 Month - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• \. 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 ℃ )
• \. 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.

You may not qualify if:

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

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (5)

People's Hospital of Baisha Li Autonomous County

Baisha, Hainan, China

Location

Haikou Hospital of the Maternal and Child Health

Haikou, Hainan, China

Location

Hainan Women and Childrens Medical Center

Haikou, Hainan, China

Location

The First Affiliated Hospital of Hainan Medical University

Haikou, Hainan, China

Location

People's Hospital of Wanning

Wanning, Hainan, China

Location

Related Publications (7)

• 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.

  PMID: 32601893 BACKGROUND

• 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.

  PMID: 31060951 BACKGROUND

• 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.

  PMID: 22475858 BACKGROUND

• 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.

  PMID: 34485957 BACKGROUND

• 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.

  PMID: 28745918 BACKGROUND

• 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.

  PMID: 24349263 BACKGROUND

• 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.

  PMID: 35841380 BACKGROUND

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Wenhong Zhang, M.D.

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Division of Infectious Diseases Affiliation: Huashan Hospital

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: June 22, 2023
• Study Start: April 24, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: August 8, 2025

Record last verified: 2023-06

Locations

CN (5)