NCT06141395

NGS-Based Assay of Blood Samples of Sepsis Patients for Rapid Bacterial Identification

Development Of A Non-Interventional Diagnostic Ngs-Based Assay Of Blood Samples Of Sepsis Patients For Rapid Bacterial Identification Based On Next Generation Sequencing.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Hellenic Institute for the Study of Sepsis · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Rapid detection of microorganisms is a promising approach towards early administration of appropriate antibiotics for sepsis. This study aims to investigate the potential of a new NGS platform for the rapid diagnosis of circulating bacteria in blood.

Detailed description

Early start of antimicrobials is the cornerstone of management of critically ill patients. The appropriate time window for this early intervention may vary greatly, but it is considered to be one to 3 hours from hospital admission. However, the choice of the antimicrobials for early intervention relies on empirical selection and may several times be inappropriate due to the emergence of antimicrobial resistance. The only way to overcome this difficulty is guidance through early microbial identification and antibiotic susceptibility testing (AST). However, blood cultures are positive in almost 20% of critically ill patients and AST may delay as much as 72 hours. This means that another type of approach is warranted which will tackle the major limitation of standard-of-care (SoC) microbiology, namely, the need to incubate whole blood into flasks enriched with growth media which necessitates subculturing once a blood flask turns positive. It is evident that rapid identification of the pathogen followed by AST using whole blood without the need of blood culture can be a major advance in the diagnostic field. The present study is based on previous analysis of ethylenediaminetetraacetic acid (EDTA) whole blood coming from patients with known bloodstream infection. Next generation sequencing (NGS) of bacterial DNA extracted from whole blood managed to identify the correct pathogen. This study is aiming at the validation of this NGS -based assay in a broader number of patients.

Conditions

• Pneumonia
• Acute Pyelonephritis
• Bacteremia
• Biliary Tract Infection

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	NGS-based assay for bacterial identification	A total volume of 26ml of whole blood will be sampled from each enrolled patient for three consecutive days. This will be used for Standard-of-Care (SoC) culture and Next Generation Sequencing (NGS), for identification of circulating microorganisms.

Timeline

• Start date: 2023-11-16
• Primary completion: 2024-03-14
• Completion: 2024-03-14
• First posted: 2023-11-21
• Last updated: 2024-03-29

Locations

4 sites across 1 country: Greece