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NCT Number: NCT05815628

Next-Generation-Sequencing Approach to Neutropenic Sepsis

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Cologne, Cologne, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

DISQVER

Diagnostic Test

NGS based infection diagnosis

Primary outcomes

  1. Evaluation of the performance of a NGS-based

    Time frame: Baseline

    Number of Participants with detection of pathogen

Secondary outcomes

  1. Average process time for NGS-based measurements

    Time frame: Baseline

    Timeframe of sampling to result of NGS-based sampling

Study contacts

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

Boris Böll

CONTACT

[email protected]

+4922147842579

Jorge Garcia Borrega

CONTACT

[email protected]

+4922147842579

Sponsors and collaborators

Lead sponsor

Boris Böll

Other

Collaborators

  • Noscendo GmbH

Registry information

Acronym: NEXUS

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 18, 2023
Registry last updated
Aug 8, 2025

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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