Next-Generation-Sequencing Approach to Neutropenic Sepsis

Boris Böll400 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

400

Conditions

Febrile Neutropenia

Interventions

DISQVERDIAGNOSTIC_TEST

NGS based infection diagnosis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

University Hospital of Cologne

Cologne, Germany

RECRUITING

Hospital Dessau

Dessau, Germany

RECRUITING

University Hospital of Essen

Essen, Germany

Outcomes

Primary Outcomes

Evaluation of the performance of a NGS-based

Number of Participants with detection of pathogen

Time frame: Baseline

Secondary Outcomes

Average process time for NGS-based measurements

Timeframe of sampling to result of NGS-based sampling

Time frame: Baseline

Central Contacts

Boris Böll

CONTACT

+4922147842579 boris.boell@uk-koeln.de

Jorge Garcia Borrega

CONTACT

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.