Next-Generation-Sequencing Approach to Neutropenic Sepsis (NEXUS)

Boris Böll

Status: Enrolling

Conditions: Febrile Neutropenia

Treatments: Diagnostic Test: DISQVER

Study type: Observational

Funder types: Other

Identifiers

NCT05815628

NEXUS-5058

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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