Evaluation of the Performance of a New Rapid Bacteremia Test in the Intensive Care Patient

NCT06241248 | Completed

• 1 other identifier: CHUBX 2023/28
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Sepsis is a serious health problem with a very high mortality in the ICU. The most important treatment for sepsis is the fastest possible antibiotic therapy. The identification of the pathogen responsible for sepsis is essential to propose an appropriate antibiotic treatment. However, the diagnosis of bacteremia by blood culture requires an average delay of 48 to 72 hours. The new test proposed by OCEAN Dx makes it possible to identify a bacteremia in a few hours. The main objective of the study is to evaluate the performance of the rapid identification test for bacteremia proposed by OCEAN Dx compared to a classic diagnostic strategy using blood cultures.

Conditions

Sepsis

Keywords

Intensive Care; Blood culture; Bacteremia; Rapid Diagnostic Tests; Antimicrobial resistance

Outcome Measures

Primary Outcomes (1)

• Comparison between OCEAN test and gold standard

  Agreement between the OCEAN Dx test results and blood cultures, gold standard of bacteriemia identification.

  1 month after inclusion day

Secondary Outcomes (3)

• Positivity rate

  1 month after inclusion day

• Delay of positivity

  1 month after inclusion day

• Impact of Ocean test on antibiotic therapy adaptation.

  1 month after inclusion day

Study Arms (1)

Ocean Test

The OCEAN Dx tests for the diagnosis of sepsis will be performed on 9 milliliters of blood collected at the patient's bedside.The sample will be collected at the same time as the blood cultures are taken. The blood tubes will then be transported to OCEAN Dx laboratories.

Diagnostic Test: Rapid sepsis diagnostic test

Interventions

Rapid sepsis diagnostic test DIAGNOSTIC_TEST

The different stages of the OCEAN Dx whole blood bacterial identification test. Identification is carried out using 9 ml of whole blood taken at the patient's bedside, and is provided after comparing the DNA sequence of the bacteria with a database. The rapid sepsis diagnostic test developed by OCEAN Dx can identify the bacteria responsible for the infection in just 4 hours at present, and soon in 3 hours. Subject to future innovations, it will probably even be possible to obtain a positive result for the presence of bacteria in the patient's sample in just 2 hours.

Ocean Test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to an intensive care unit (ICU) with a suspected or documented infection requiring blood cultures

You may qualify if:

• Patients over 18 years of age admitted to an intensive care unit (ICU) with a suspected or documented infection requiring blood cultures.

You may not qualify if:

• Patient under 18 years of age
• Pregnant or breastfeeding woman
• Patient of legal age, under guardianship or deprived of liberty
• Not affiliated to a social security regime or not benefiting from such a regime.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

Hopital Haut-Lévêque

Pessac, 33604, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood bacterial

MeSH Terms

Conditions

Sepsis; Bacteremia

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bacterial Infections; Bacterial Infections and Mycoses

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: February 5, 2024
• Study Start: May 13, 2024
• Primary Completion: June 10, 2025
• Study Completion: June 10, 2025
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)