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NCT Number: NCT06624618

Rapid Molecular Diagnosis of Sepsis in the Intensive Care Unit

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Maastricht University Medical Center

Maastricht, Limburg, 6229 HX, Netherlands

Location status: Recruiting

Location contact

Anna Wijen, Msc

CONTACT

[email protected]

0031626882868

Anna Wijen, Msc

CONTACT

Christian von Wintersdorff, Dr.

CONTACT

Dennis Bergmans, Dr.

CONTACT

Paul Savelkoul, Prof. Dr.

CONTACT

[email protected]

0031433876644

Paul Savelkoul, Prof. Dr.

CONTACT

Rob Driessen, Dr.

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-N/A

Treatment and study plan

Primary outcomes

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

    Time frame: 2 years

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

  2. Patterns of bacterial DNA dynamics over time

    Time frame: 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 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

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Wijen, Msc.

CONTACT

[email protected]

+31 626882868

Paul Savelkoul, Prof. Dr.

CONTACT

[email protected]

+31 433876610

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Health Holland

Registry information

Official study title

Rapid Molecular Detection of Sepsis in Whole Blood

Acronym: RADOS

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 3, 2024
Registry last updated
Oct 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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