Next-Generation-Sequencing Approach to Neutropenic Sepsis
ConditionFebrile Neutropenia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBoris Böll
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial population
400 neutropenic patients with febrile neutropenia
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
DISQVER
Diagnostic testNGS based infection diagnosis
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Evaluation of the performance of a NGS-based
Number of Participants with detection of pathogen
Time frame
BaselineSecondary outcomes
1
Average process time for NGS-based measurements
Timeframe of sampling to result of NGS-based sampling
Time frame
BaselineSponsors and contacts
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Source ClinicalTrials.gov