PneumoniaNCT05912010
A Study on Pathogenic Surveillance and Nasopharyngeal Carriage of Children and Adolescents Based on Hospitals and Communities in Hainan Province
An observational study of Pneumonia, run by Huashan Hospital at 5 sites in China.
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. Read more about this study
- Who is it for?
- Ages 1 month to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Pneumonia
- What is being tested?
- NP/OP swab
- How many people
- 3,746 participants
- Where
- 5 sitesChina
- Study dates
- 24 Apr 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 10 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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 .
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
People's Hospital of Baisha Li Autonomous County
Baisha, Hainan
Haikou Hospital of the Maternal and Child Health
Haikou, Hainan
Hainan Women and Childrens Medical Center
Haikou, Hainan
The First Affiliated Hospital of Hainan Medical University
Haikou, Hainan
People's Hospital of Wanning
Wanning, Hainan
About this study
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.
Read the detailed 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.
- Conditions
- Pneumonia
- Being tested
- NP/OP swab
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NP/OP swabDiagnostic test
NP/OP (nasopharyngeal/oropharyngeal) swabs will be collected from all cases at enrollment for respiratory pathogen multiplex PCR or pneumococcus culture.
| Study group | Role | What they receive |
|---|---|---|
| case group | patients from fever clinics and pediatric wards Receives: Diagnostic Test: NP/OP swab | |
| control group | healthy community children Receives: Diagnostic Test: NP/OP swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 1 day
Secondary outcomes (2)
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.
Measured: 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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start24 Apr 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 3,746 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen-hong Zhang, Huashan Hospital
- Investigators
- Wenhong Zhang, M.D., Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05912010
- Sponsor's protocol ID
- HAPEC-Stage one 01&02
- Status last verified
- Jun 2023
- First submitted
- 12 Jun 2023
- Last updated
- 8 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: After thesis defense the study may be published internationally to be available for the public.
Publications
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.
PubMed 32601893Hocknell 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.
PubMed 31060951Jauneikaite 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.
PubMed 22475858Andrejko 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.
PubMed 34485957Lyu 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.
PubMed 28745918Zhao 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.
PubMed 24349263DeVries 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.
PubMed 35841380
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Pathogenic Surveillance and Nasopharyngeal Carriage of Children and Adolescents Based on Hospitals and Communities in Hainan Province
- ClinicalTrials.gov ID
- NCT05912010
- Acronym / sponsor ID
- HAPEC-Stage one 01&02
- Conditions
- Pneumonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,746 participants (actual)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 24 Apr 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case group | – | Diagnostic Test: NP/OP swabpatients from fever clinics and pediatric wards |
| control group | – | Diagnostic Test: NP/OP swabhealthy community children |
Who may qualify
- Ages
- 1 month to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (6 listed)
- 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 ℃ )
Key exclusion criteria (4 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NP/OP swabNP/OP (nasopharyngeal/oropharyngeal) swabs will be collected from all cases at enrollment for respiratory pathogen multiplex PCR or pneumococcus culture. | Diagnostic test | case group, control group |
Primary outcome
Prevalence of pneumococcus
Time frame: 1 day
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
Correaltion index of high load (>6.9 log10 copies/ml) pneumococcus
Time frame: 1 day
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
Correaltion index of disease status of infection with different pathogens
Time frame: 1 day
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
2 secondary outcomes
Estimate the proportions of srotypes in patients and healthy children
Time frame: 1 day
Describe the resistance proportion of antibiotics in different region in Hainan
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Results publication: PubMed 32601893Alizadeh 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.
- Results publication: PubMed 31060951Hocknell 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.
- Results publication: PubMed 22475858Jauneikaite 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.
- Results publication: PubMed 34485957Andrejko 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.
- Results publication: PubMed 28745918Lyu 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.
- Results publication: PubMed 24349263Zhao 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.
- Results publication: PubMed 35841380DeVries 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.
- Individual participant dataSharing planned: Undecided. After thesis defense the study may be published internationally to be available for the public.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wenhong Zhang, M.D. principal investigator
Huashan Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia, run by Huashan Hospital at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of pneumococcus (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05912010, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.