Monitoring of Antimicrobial Resistance Based on Metagenomics Analyses in Pneumonia Patients

NCT06566898 | Recruiting

• 1 other identifier: 2023234
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

Monitoring of antimicrobial resistance (AMR) based on metagenomics analyses in pneumonia patients is critical for optimizing clinical diagnosis and treatment and improving clinical prognosis. This study is designed to ask the following key questions:

1. 1.What is the microbiome maps of patients with severe pneumonia and mild pneumonia ?
2. 2.How many pathogen resistance genes are carrying in severe pneumonia and mild pneumonia ?
3. 3.What is the genetic diversity of key pathogens detected in severe pneumonia and mild pneumonia during 2019-2025?

Conditions

Pneumonia; Next-generation Sequencing; Microbiome; Antimicrobial Resistance

Keywords

Pneumonia; Next-generation sequencing; Microbiome; Antimicrobial Resistance

Outcome Measures

Primary Outcomes (1)

• Microbiome composition

  a collection of microbial communities detected in the biospecimen

  during the study period, 2019-2025

Secondary Outcomes (3)

• Alpha diversity

  during the study period, 2019-2025

• Prevalence of bacterial resistance genes

  during the study period, 2019-2025

• Beta diversity

  during the study period, 2019-2025

Study Arms (2)

Severe pneumonia

Patients clinically diagnosed as severe pneumonia are diagnosed according to the Guidelines for the diagnosis and Treatment of community-acquired pneumonia in Adults (2019 edition) formulated by the American Thoracic Society (ATS) and the Infectious Diseases Society of America (IDSA), who meet 1 of the following major criteria or ≥3 minor criteria can be diagnosed. The diagnostic criteria for severe pneumonia in children were adopted by the British Thoracic Society (BTS) in 2011.

Mild pneumonia

Patients clinically diagnosed as severe pneumonia and mild pneumonia are diagnosed according to the Guidelines for the diagnosis and Treatment of community-acquired pneumonia in Adults (2019 edition) formulated by the American Thoracic Society (ATS) and the Infectious Diseases Society of America (IDSA). The diagnostic criteria for severe and mild pneumonia in children were adopted by the British Thoracic Society (BTS) in 2011

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pneumonia patients from four centers in China during 2022-2025.

You may qualify if:

• Patients clinically diagnosed as severe pneumonia and mild pneumonia are diagnosed according to the Guidelines for the diagnosis and Treatment of community-acquired pneumonia in Adults (2019 edition) formulated by the American Thoracic Society (ATS) and the Infectious Diseases Society of America (IDSA), who meet 1 of the following major criteria or ≥3 minor criteria can be diagnosed. The diagnostic criteria for severe and mild pneumonia in children were adopted by the British Thoracic Society (BTS) in 2011.
• Clinical examination was performed, and there was biospecimen (nasopharyngeal swab, oropharyngeal swab, bronchoalveolar lavage fluid, sputum, blood, hydrothorax, lung tissue) remaining in the clinical microbiological examination.

You may not qualify if:

• Patients whose biological samples may be contaminated;
• Patients with alveolar lavage fluid or hydrothorax volume less than 200μl.

Sponsors & Collaborators

• Shanghai General Hospital, China: lead
• Wuxi People's Hospital Affiliated to Nanjing Medical University: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• The Central Hospital of Huanggang: collaborator

Study Sites (1)

Mei Kang

Shanghai, Shanghai Municipality, 200080, China

RECRUITING

Related Publications (19)

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  PMID: 31665441 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Nasopharyngeal swab, oropharyngeal swab, bronchoalveolar lavage fluid, sputum, blood, hydrothorax, lung tissue.

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

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

Study Officials

• Mei Kang, MPH

  Shanghai General Hospital, Shanghai Jiaotong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mei Kang, MPH

CONTACT

18501709576; mei.kang@shgh.cn

Xue Tian, Master

CONTACT

02163240090; xue.tian@shgh.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 18, 2024
• First Posted: August 22, 2024
• Study Start: August 1, 2024
• Primary Completion: April 15, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

CN (1)