Detection of Pathogen and Antibiotic Resistance Genes by Targeted Next-Generation Sequencing in ICU Patients.

Sun Yat-sen University

Status: Not yet enrolling

Conditions: Diagnosis; Critical Illness; Infections

Treatments: Diagnostic Test: targeted next-generation sequencing (tNGS)

Study type: Observational

Funder types: Other

Identifiers

NCT06157372

SYSKY-2023-667-03

Details and patient eligibility

About

It is difficult to determine the pathogens in the early stage of infection in critically ill patients, and empirical use of broad-spectrum antibiotics for a long time is often necessary, leading to antibiotics drug resistance. Targeted next generation sequencing (tNGS) can provide faster results for pathogen and related antibiotic resistant diagnosis. But it lacks sufficient clinical evidence. Evidence regarding the clinical diagnostic accuracy and drug resistance is needed to comprehensively evaluate targeted next generation sequencing (tNGS) for diagnosis of patients in ICU who and will be critical to inform national policy.

Full description

Infectious diseases are one of the highest mortality and morbidity diseases in humans. Due to the difficulty in identifying the pathogen in the early stage of infection, patients with severe infections often need to empirically use broad-spectrum antimicrobials for a long time. The traditional gold standard of etiological detection - etiological culture, even in sepsis patients, only about 60% of the results are positive. Therefore, the accurate identification and rapid classification of pathogenic microorganisms is very important for the patient's precise diagnosis and timely treatment.

Metagenomic next generation sequencing (mNGS), which has emerged in recent years, have been shown to provide early diagnosis and targeted medication guidance for bloodstream infections and respiratory infections, but it is expensive and not able to provide related drug resistant genes. Therefore, targeted next generation sequencing (tNGS) has been derived, which is characterized by rapid sequencing and genetic testing for drug resistance.

The purpose of this study is to evaluate the efficacy of etiological diagnosis and provide patients with more accurate treatment.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The presence of an infection or clearly excluded the presence of infection.
• Etiological culture and/or metagenomic next-generation sequencing detection of specimens sent for testing.

Exclusion criteria

• Suspected infection.
• Participation in other clinical trials in the past 2 months.

Trial design

20 participants in 2 patient groups

Non-Infection group

Description:

Participants received traditional etiological culture of suspected site of infection.

Treatment:

Diagnostic Test: targeted next-generation sequencing (tNGS)

Infection group

Description:

Participants received traditional etiological culture, metagenomic next-generation sequencing of infectious sites.

Treatment:

Diagnostic Test: targeted next-generation sequencing (tNGS)