Pathogen surveillance in children with pneumonia in Hainan Province

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

This study is testing how common a germ called Streptococcus pneumoniae is in children with pneumonia and healthy kids in Hainan Province to help improve vaccine use in the area.

Quick facts

• Study type: Observational
• Enrollment: 6000 (estimated)
• Ages: 1 Month to 10 Years
• Sex: All
• Sponsor: Huashan Hospital (Academic / other)
• Locations: 5 sites (Baisha, Hainan and 4 other locations)
• Trial ID: NCT05912010 on ClinicalTrials.gov

What this trial studies

This observational study aims to screen children under 10 years old for respiratory pathogens, specifically Streptococcus pneumoniae, in three cities of Hainan Province: Haikou, Wanning, and Baisha. It will assess the carrier status, pathogen spectrum, serotype distribution, and drug resistance profiles of Streptococcus pneumoniae in both clinically diagnosed pneumonia cases and healthy children from the community. The findings will help lay the groundwork for promoting Streptococcus pneumoniae vaccines in the region.

Who should consider this trial

Good fit: Ideal candidates include children under 10 years old who are clinically diagnosed with pneumonia or are healthy controls from the community.

Not a fit: Patients who are older than 10 years or do not have pneumonia symptoms will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the understanding of pneumonia pathogens in children and support the development of effective vaccination strategies.

How similar studies have performed: Other studies have shown success in similar epidemiological approaches to understanding pneumonia pathogens, indicating potential for valuable insights.

Eligibility criteria

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 .

Where this trial is running

Baisha, Hainan and 4 other locations

• People's Hospital of Baisha Li Autonomous County — Baisha, Hainan, China (Recruiting)
• Haikou Hospital of the Maternal and Child Health — Haikou, Hainan, China (Not_yet_recruiting)
• Hainan Women and Childrens Medical Center — Haikou, Hainan, China (Not_yet_recruiting)
• The First Affiliated Hospital of Hainan Medical University — Haikou, Hainan, China (Not_yet_recruiting)
• People's Hospital of Wanning — Wanning, Hainan, China (Recruiting)

Study contacts

• Principal investigator: Wenhong Zhang, M.D. — Huashan Hospital
• Study coordinator: Jingwen Ai, M.D.

Conditions Pneumonia