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

Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05912010
• Other study ID #: HAPEC-Stage one 01&02
• Status: Recruiting
• Start date: April 24, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2023
• Source: Huashan Hospital
• Contact: Jingwen Ai, M.D.
• Phone: +86 13764990804
• Email: Jingwenai1990[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6000
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Month to 10 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Pneumonia

Intervention

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

Locations

Country	Name	City	State
China	People's Hospital of Baisha Li Autonomous County	Baisha	Hainan
China	Haikou Hospital of the Maternal and Child Health	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

Sponsors (1)

Lead Sponsor	Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

References & 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 — View Citation

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. La — View Citation

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.1544 — View Citation

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. — View Citation

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 — View Citation

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 — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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