Rapid Molecular Diagnosis of Sepsis in the Intensive Care Unit

NCT06624618 | Recruiting DMC

• 1 other identifier: 2023-0344
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Bloodstream Infection

Keywords

Culture-free; Whole blood; Molecular diagnosis; Sepsis; Bloodstream infection; Bacterial DNA

Outcome Measures

Primary Outcomes (2)

• Development and validation of rapid diagnostics tests for detection of bacterial DNA in sepsis

  The tests will report presence of bacterial DNA by giving a specific bacterial species name.

  2 years

• Patterns of bacterial DNA dynamics over time

  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.

  2 years

Secondary Outcomes (1)

• 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

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 at the Intensive Care Unit (ICU) of Maastricht University Medical Center (MUMC) are eligible.

You may qualify if:

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

You may not qualify if:

• N/A

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Health Holland: collaborator

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6229 HX, Netherlands

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Lysed whole blood samples from which microbial DNA has been isolated

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Anna Wijen, Msc.

CONTACT

+31 626882868; anna.wijen@maastrichtuniversity.nl

Paul Savelkoul, Prof. Dr.

CONTACT

+31 433876610; paul.savelkoul@mumc.nl

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: October 3, 2024
• Study Start: May 1, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: October 3, 2024

Record last verified: 2024-10

Locations

NL (1)