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NCT Number: NCT06141395

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

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.

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Key information

Conditions

Pneumonia Acute Pyelonephritis Bacteremia Bacterial Infections Bacterial Infections and Mycoses Bile Duct Diseases Biliary Tract Diseases Biliary Tract Infection Cholangitis Digestive System Diseases Infections Inflammation Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Infections Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

4th Department of Internal Medicine,"Attikon" University Hospital, National and Kapodistrian University of Athens, Medical School, Chaïdári, Attica, Greece

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age equal to or above 18 years.
  • Both genders.
  • Written informed consent provided by the patient or by one first-degree relative/spouse in case of patients unable to consent.
  • Patients with high suspicion of infection with at least one sign of the quick SOFA score (i.e. one of mental confusion, more than 22 breaths per minute or systolic blood pressure less than 100mmHg).

Exclusion criteria

  • Age below 18 years.
  • Denial for written informed consent.
  • Patients already receiving antibiotics.
  • Pregnancy or lactation.

Treatment and study plan

NGS-based assay for bacterial identification

Diagnostic Test

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.

Primary outcomes

  1. The rate of matching between the results of Next Generation Sequencing and the Standard-of-Care culture for patients with sepsis.

    Time frame: 7 days

    This will be done by assessing the sensitivity, the specificity, the positive predictive value and the negative predictive value of Next Generation Sequencing and Standard-of-Care. For the analysis of this diagnostic performance, the results of the SoC cultures will be considered the "gold standard" for comparisons.

Secondary outcomes

  1. Difference in time to identification of the bacterial pathogen between Next Generation Sequencing and the Standard-of-Care culture

    Time frame: 7 days

    The time from start of incubation until final identification will be recorded and compared between the two methods.

  2. Difference in time to Antibiotic Susceptibility Testing between Next Generation Sequencing and the Standard-of-Care culture

    Time frame: 7 days

    The time from start of incubation until the Antibiotic Susceptibility Testing will be recorded and compared between the two methods.

Sponsors and collaborators

Lead sponsor

Hellenic Institute for the Study of Sepsis

Other

Collaborators

  • The BioArte

Registry information

Official study title

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

Acronym: BIOARTE

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 21, 2023
Registry last updated
Mar 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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