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NEXUS: Next-Generation-Sequencing Approach to Neutropenic Sepsis

Sponsor
Boris Böll (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05815628
Collaborator
Noscendo GmbH (Other)
400
Enrollment
26
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: DISQVER

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 Design

Study Type:
Observational
Anticipated Enrollment :
400 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Next-Generation-Sequencing Approach to Neutropenic Sepsis
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
May 1, 2025
Anticipated Study Completion Date :
Jul 1, 2025

Outcome Measures

Primary Outcome Measures

  1. Evaluation of the performance of a NGS-based [Baseline]

    Number of Participants with detection of pathogen

Secondary Outcome Measures

  1. Average process time for NGS-based measurements [Baseline]

    Timeframe of sampling to result of NGS-based sampling

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Boris Böll
  • Noscendo GmbH

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Boris Böll, Principal Investigator, Clinical Professor, University Hospital of Cologne
ClinicalTrials.gov Identifier:
NCT05815628
Other Study ID Numbers:
  • NEXUS-5058
First Posted:
Apr 18, 2023
Last Update Posted:
Apr 20, 2023
Last Verified:
Apr 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Neutropenia
Febrile Neutropenia

Study Results

No Results Posted as of Apr 20, 2023