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Clinical Trials in China / NCT07035535
Enrolling by invitation Observational

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

NCT07035535 · tracked via the Priya Life Science China tracker
Sponsor
The First Affiliated Hospital with Nanjing Medical University
Phase
Observational
Started
2023-01-01
Last updated
2025-07-28

Condition(s) studied

Antimicrobial Drug ResistanceHigh-Throughput Nucleotide Sequencing

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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 sites (1)

FacilityCityRegionStatus
First Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07035535 on ClinicalTrials.gov ↗ ← All trials in China