Next-Generation-Sequencing Approach to Neutropenic Sepsis

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05815628

Acronym

NEXUS

Enrollment

400

Registered

2023-04-18

Start date

2024-06-05

Completion date

2026-11-01

Last updated

2025-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Febrile Neutropenia

Brief 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.

Detailed 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.

Interventions

DIAGNOSTIC_TESTDISQVER

NGS based infection diagnosis

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Evaluation of the performance of a NGS-based	Baseline	Number of Participants with detection of pathogen

Secondary

Measure	Time frame	Description
Average process time for NGS-based measurements	Baseline	Timeframe of sampling to result of NGS-based sampling

Countries

Germany

Contacts

Primary ContactBoris Böll

boris.boell@uk-koeln.de+4922147842579

Backup ContactJorge Garcia Borrega

jorge.garcia-borrega@uk-koeln.de+4922147842579

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026