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Rapid Molecular Diagnosis of Sepsis in the Intensive Care Unit

NCT ID: NCT06624618

Last Updated: 2024-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-01

Study Completion Date

2026-05-01

Brief Summary

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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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Detailed Description

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Conditions

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Sepsis Bloodstream Infection

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

-N/A
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Health Holland

OTHER

Sponsor Role collaborator

Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Maastricht University Medical Center

Maastricht, Limburg, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Anna Wijen, Msc.

Role: CONTACT

[email protected]
+31 626882868

Paul Savelkoul, Prof. Dr.

Role: CONTACT

[email protected]
+31 433876610

Facility Contacts

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Anna Wijen, Msc

Role: primary

[email protected]
0031626882868

Paul Savelkoul, Prof. Dr.

Role: backup

[email protected]
0031433876644

Paul Savelkoul, Prof. Dr.

Role: backup

Anna Wijen, Msc

Role: backup

Christian von Wintersdorff, Dr.

Role: backup

Rob Driessen, Dr.

Role: backup

Dennis Bergmans, Dr.

Role: backup

Other Identifiers

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2023-0344

Identifier Type: -

Identifier Source: org_study_id

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