Rapid Molecular Diagnosis of Sepsis in the Intensive Care Unit

Recruiting

• Conditions: Sepsis; Bloodstream Infection

• Registration Number: NCT06624618
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

Rapid diagnosis of sepsis is crucial for treatment and survival. Currently, blood culture takes 48 hours-5 days to complete. After starting antimicrobial treatment blood culture results are not reliable. As a result, empirical broad spectrum antimicrobial therapy is mostly used. This implies possible antimicrobial over- or under treatment which is associated with increased antimicrobial resistance development. Early identification of the causative pathogen of sepsis will therefore have a major impact on the adequate treatment and reduction of high mortality rates. To date, there is not a single molecular diagnostic test available on the market to detect all putative causative bacterial pathogens of sepsis. In this study, the investigators will develop and validate a completely new molecular sepsis approach based on pathogen DNA detection, as an alternative to culture.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-30
• Study Start: 2024-05-01
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-01
• Last Update Submitted: 2024-10-01
• Study First Posted: 2024-10-03
• Last Update Posted: 2024-10-03
• Primary Completion: 2026-05-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

-Patients are included when routine blood cultures are ordered for diagnosis of bloodstream infections.

Exclusion Criteria

-N/A

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Development and validation of rapid diagnostics tests for detection of bacterial DNA in sepsis	2 years	The tests will report presence of bacterial DNA by giving a specific bacterial species name.
Patterns of bacterial DNA dynamics over time	2 years	Use of species-specific qPCR primers (either from existing sepsis literature or to be designed) to quantify the DNA load at at least 3 different time points during an infectious episode. Comparison of these loads with infectious parameters used for routine diagnostics and with antibiotic use.

Secondary Outcome Measures

Name	Time	Method
Distinguishing between the causative pathogen and contamination by a physician evaluation panel, both for the current gold standard (blood cultures) and the results of new microbiological tests for detecting sepsis pathogens	2 years

Trial Locations

Locations (1)

Maastricht University Medical Center; 🇳🇱 Maastricht, Limburg, Netherlands