The Predictive Value of Molecular Diagnostic Techniques in the Antimicrobial- Resistance Phenotypes of Pathogens

• Conditions: Antimicrobial Drug Resistance; High-Throughput Nucleotide Sequencing

• Registration Number: NCT07035535
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Brief Summary

This observational study is to learn about the predictive value of targeted next-generation sequencing(tNGS) in pathogen resistance phenotype of patients with lower respiratory tract infection ,by detecting antimicrobial-resistant genes.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Study First Submitted: 2025-05-19
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-15
• Last Update Submitted: 2025-06-15
• Study First Posted: 2025-06-25
• Last Update Posted: 2025-06-25
• Primary Completion: 2025-06-28
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Aged 18 years and above
• Lower respiratory tract infection based on at least two of the followings: abnormal temperature (body temperature greater than 38.5°C or less than 36.5°C), leucocyte count abnormality (leucocyte count greater than 10*10^9/L or less than 4*10^9/L), and the presence of purulent tracheal secretions.
• Patients have been performed tNGS test in-hospital, with the criterion that the reads per kilobase per million mapped reads(RPKM) for staphylococcus aureus exceeds 200, acinetobacter baumannii exceeds 300, klebsiella pneumoniae exceeds 20, or pseudomonas aeruginosa exceeds 100.

Exclusion Criteria

• Klebsiella pneumoniae，acinetobacter baumannii,pseudomonas aeruginosa or staphylococcus aureus were not cultured in BALF.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The outcome of the antimicrobial-resistance genes by tNGS	Up to 2 weeks after enrollment	The investigators use the targeted next-generation sequencing(tNGS) to detect the antimicrobial-resistance genes produced by klebsiella pneumoniae，acinetobacter baumannii,pseudomonas aeruginosa or staphylococcus aureus in patients with lower respiratory tract infections
The outcome of bacteria antimicrobial susceptibility test	Up to 2 weeks after enrollment	The antimicrobial susceptibility test(AST) results of the klebsiella pneumoniae，acinetobacter baumannii,pseudomonas aeruginosa or staphylococcus aureus.

Trial Locations

Locations (1)

First Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China