Next-Generation-Sequencing Approach to Neutropenic Sepsis

Recruiting

• Conditions: Febrile Neutropenia

• Registration Number: NCT05815628
• Lead Sponsor: Boris Böll

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.

Study Timeline

• Study First Submitted: 2023-03-09
• Study First Submitted QC: 2023-04-03
• Study First Posted: 2023-04-18
• Study Start: 2024-06-05
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-14
• Primary Completion: 2025-11-30
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of the performance of a NGS-based	Baseline	Number of Participants with detection of pathogen

Secondary Outcome Measures

Name	Time	Method
Average process time for NGS-based measurements	Baseline	Timeframe of sampling to result of NGS-based sampling

Trial Locations

Locations (6)

University Hospital of Essen; 🇩🇪 Essen, Germany

Hospital Dessau; 🇩🇪 Dessau-Rosslau, Germany

University Hospital of Frankfurt; 🇩🇪 Frankfurt am Main, Germany

University Hospital of Leipzig; 🇩🇪 Leipzig, Germany

University Hospital of Magdeburg; 🇩🇪 Magdeburg, Germany

University Hospital of Cologne; 🇩🇪 Cologne, Germany