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

Fudan University logo

Fudan University

Status

Completed

Conditions

Pneumonia

Treatments

Diagnostic Test: NP/OP swab

Study type

Observational

Funder types

Other

Identifiers

NCT05912010
HAPEC-Stage one 01&02

Details and patient eligibility

About

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.

Full 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.

Enrollment

3,746 patients

Sex

All

Ages

1 month to 10 years old

Volunteers

Accepts Healthy Volunteers

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 ℃ )

      1. 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 ;
    1. People who affect the research results: patients cannot keep samples or the amount of samples is not enough for testing;
    1. Can't cooperate well;
    1. The researcher judges that it is not suitable to be included in this study .

Trial design

3,746 participants in 2 patient groups

case group
Description:
patients from fever clinics and pediatric wards
Treatment:
Diagnostic Test: NP/OP swab
control group
Description:
healthy community children
Treatment:
Diagnostic Test: NP/OP swab

Trial contacts and locations

5

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Central trial contact

Jingwen Ai, M.D.

Data sourced from clinicaltrials.gov

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