Next-Generation-Sequencing Approach to Neutropenic Sepsis

Febrile Neutropenia Clinical Trial

— NEXUS  

Official title:

Next-Generation-Sequencing Approach to Neutropenic Sepsis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05815628
• Other study ID #: NEXUS-5058
• Status: Not yet recruiting
• Start date: June 1, 2024
• Est. completion date: July 1, 2025

Study information

• Verified date: May 2024
• Source: University Hospital of Cologne
• Contact: Boris Böll
• Phone: +4922147842579
• Email: boris.boell[@]uk-koeln.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this prospective, observational, non-interventional, multi-centre study of the diagnostic use of DISQVER in neutropenic patients with FN is to provide further evidence of the efficacy of an NGS-based approach for detecting bloodstream infection in neutropenic patients.

Description:

The aim of this prospective, observational, non-interventional, multi-centre study of the diagnostic use of DISQVER (Platform for digital pathogen diagnostics from Noscendo GmbH) in neutropenic patients with FN (Febrile neutropenia) is to provide further evidence of the efficacy of an NGS (Next-generation seqzencing)-based approach for detecting bloodstream infection in neutropenic patients.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: July 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age =18 years

• Informed consent

• Neutropenia defined as <500 ANC (Absolute neutrophil Count)/µl or <1000 WBC (White bloddcell Count)/µl if ANC is not available

• Fever (with an onset < 24h) or Sepsis (with an onset <24h) Patients with a life-threatening - organ dysfunction caused by a dysregulated host response to a suspected or proven infection.

Exclusion Criteria:

• Age < 18 years

• Refusal or inability to give consent Inability to give informed consent if no acceptable patient representative is available

• Patients who had previously been included, but develop a new episode of fever during the same hospitalization, will not be included a second time

• Death is deemed imminent and inevitable

Related Conditions & MeSH terms

• Febrile Neutropenia
• Neutropenia

Intervention

Diagnostic Test:
• DISQVER
NGS based infection diagnosis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Boris Böll	Noscendo GmbH

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the performance of a NGS-based	Number of Participants with detection of pathogen	Baseline
Secondary	Average process time for NGS-based measurements	Timeframe of sampling to result of NGS-based sampling	Baseline