Rapid Molecular Diagnosis of Sepsis in the Intensive Care Unit

Trial statusCompleted
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMaastricht University Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

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

Trial design

Design model

Case-only

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
2 years
2

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.

Time frame
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

Time frame
2 years

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: