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

Recruiting

• Conditions: Sepsis
• Interventions: Diagnostic Test: Rapid sepsis diagnostic test

• Registration Number: NCT06241248
• Lead Sponsor: University Hospital, Bordeaux

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.

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 Timeline

• Study First Submitted: 2024-01-26
• Study First Submitted QC: 2024-02-02
• Study First Posted: 2024-02-05
• Status Verified: 2024-05
• Study Start: 2024-05-13
• Last Update Submitted: 2024-05-17
• Last Update Posted: 2024-05-20
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ocean Test	Rapid sepsis diagnostic 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.

Primary Outcome Measures

Name	Time	Method
Comparison between OCEAN test and gold standard	1 month after inclusion day	Agreement between the OCEAN Dx test results and blood cultures, gold standard of bacteriemia identification.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hopital Haut-Lévêque; 🇫🇷 Pessac, France