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

The Predictive Value of Targeted Next-generation Sequencing(tNGS) in the Antimicrobial- Resistance Phenotypes of Pathogens

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07035535

Enrollment

200

Registered

2025-06-25

Start date

2023-01-01

Completion date

2025-12-31

Last updated

2025-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antimicrobial Drug Resistance, High-Throughput Nucleotide Sequencing

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

China

Outcome results