Next-Generation-Sequencing Approach to Neutropenic Sepsis

Last updated: March 11, 2025
Sponsor: Boris Böll
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neutropenia

Treatment

DISQVER

Clinical Study ID

NCT05815628
NEXUS-5058
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥18 years

  • Informed consent

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

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

Exclusion

Exclusion Criteria:

  • Age < 18 years

  • Refusal or inability to give consent Inability to give informed consent if noacceptable patient representative is available

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

  • Death is deemed imminent and inevitable

Study Design

Total Participants: 400
Treatment Group(s): 1
Primary Treatment: DISQVER
Phase:
Study Start date:
June 05, 2024
Estimated Completion Date:
January 01, 2026

Study 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.

Connect with a study center

  • University Hospital of Cologne

    Cologne,
    Germany

    Active - Recruiting

  • Hospital Dessau

    Dessau-Rosslau, 06847
    Germany

    Active - Recruiting

  • University Hospital of Essen

    Essen, 45147
    Germany

    Site Not Available

  • University Hospital of Frankfurt

    Frankfurt am Main, 60590
    Germany

    Active - Recruiting

  • University Hospital of Leipzig

    Leipzig, 04103
    Germany

    Active - Recruiting

  • University Hospital of Magdeburg

    Magdeburg, 39120
    Germany

    Active - Recruiting

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