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

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.

Study Overview

• Status: Completed
• Conditions: Sepsis
• Intervention / Treatment: Diagnostic test: Rapid sepsis diagnostic test

Detailed Description

Sepsis is a worldwide problem. The World Health Organization estimates that around 49 million people suffer from sepsis each year. It is responsible for an unacceptable number of deaths, estimated at around 11 million. The severity of sepsis is not only related to the infection itself, but often to a too late diagnosis and an important heterogeneity in the management of patients. The identification of the pathogen responsible for sepsis is currently based on the positivity of bacteriological samples, particularly blood cultures. However, the diagnosis of bacteremia by blood cultures requires an average delay of 48 to 72 hours, which is not conducive to rapid adaptation of antibiotic therapy. The test proposed by OCEAN Dx offers the identification of a bacteremia in a few hours thanks to the recognition of the bacterial DNA in the patient's blood. The main objective of the study is to evaluate the performance of the rapid identification test for bacteremia offered by OCEAN Dx in comparison with a classical diagnostic strategy using blood cultures.

• Study Type: Observational
• Enrollment (Actual): 110

Contacts and Locations

Study Locations

• France
  • Pessac, France, 33604
    • Hôpital Haut-Lévêque

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positivity rate	The positivity rate of the OCEAN Dx test and blood cultures	1 month after inclusion day
Delay of positivity	Time to positivity of the OCEAN Dx test and blood cultures	1 month after inclusion day
Impact of Ocean test on antibiotic therapy adaptation.	Cost of prescribed antibiotics and theoretical antibiotics after de-escalation according to the identification of germs by blood cultures and the OCEAN Dx test	1 month after inclusion day

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2024
• Primary Completion (Actual): June 10, 2025
• Study Completion (Actual): June 10, 2025

Study Registration Dates

• First Submitted: January 26, 2024
• First Submitted That Met QC Criteria: February 2, 2024
• First Posted (Actual): February 5, 2024

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Bacteremia; Intensive Care; Antimicrobial resistance; Blood culture; Rapid Diagnostic Tests
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Bacterial Infections; Bacterial Infections and Mycoses; Pathological Conditions, Signs and Symptoms; Bacteremia; Sepsis
• Other Study ID Numbers: CHUBX 2023/28

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No