Next-Generation-Sequencing Approach to Neutropenic Sepsis
NEXUS
1 other identifier
observational
400
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2024
Typical duration for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 9, 2023
CompletedFirst Posted
Study publicly available on registry
April 18, 2023
CompletedStudy Start
First participant enrolled
June 5, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
August 8, 2025
August 1, 2025
2.3 years
March 9, 2023
August 7, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluation of the performance of a NGS-based
Number of Participants with detection of pathogen
Baseline
Secondary Outcomes (1)
Average process time for NGS-based measurements
Baseline
Interventions
NGS based infection diagnosis
Eligibility Criteria
400 neutropenic patients with febrile neutropenia
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boris Bölllead
- Noscendo GmbHcollaborator
Study Sites (6)
University Hospital of Cologne
Cologne, Germany
Hospital Dessau
Dessau, 06847, Germany
University Hospital of Essen
Essen, 45147, Germany
University Hospital of Frankfurt
Frankfurt am Main, 60590, Germany
University Hospital of Leipzig
Leipzig, 04103, Germany
University Hospital of Magdeburg
Magdeburg, 39120, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator, Clinical Professor
Study Record Dates
First Submitted
March 9, 2023
First Posted
April 18, 2023
Study Start
June 5, 2024
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
November 1, 2026
Last Updated
August 8, 2025
Record last verified: 2025-08