Next-Generation-Sequencing Approach to Neutropenic Sepsis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DISQVER.
- Who it may be relevant to
- Registry conditions: Febrile Neutropenia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
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 test DISQVER
NGS based infection diagnosis
Primary outcome measures
- Evaluation of the performance of a NGS-based [Time frame: Baseline]
Secondary outcome measures (1)
- Average process time for NGS-based measurements [Time frame: Baseline]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 6 centers
- University Hospital of Cologne — Cologne
- Hospital Dessau — Dessau
- University Hospital of Essen — Essen
- University Hospital of Frankfurt — Frankfurt am Main
- University Hospital of Leipzig — Leipzig
- University Hospital of Magdeburg — Magdeburg
Identifiers
NCT: NCT05815628 · NEXUS-5058