Actively Recruiting
Next-Generation-Sequencing Approach to Neutropenic Sepsis
Led by Boris Böll · Updated on 2025-08-08
400
Participants Needed
6
Research Sites
4 weeks
Total Duration
On this page
Sponsors
B
Boris Böll
Lead Sponsor
N
Noscendo GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to provide more evidence on how well a next-generation sequencing (NGS) based diagnostic tool called DISQVER works in detecting bloodstream infections in patients with febrile neutropenia, a condition marked by fever and low white blood cell counts. The study is observational and non-interventional, involving multiple centers and neutropenic patients. It focuses on evaluating the effectiveness of this digital pathogen diagnostic platform in a real-world clinical setting. Participants will undergo diagnostic testing using the DISQVER platform, which uses NGS technology to identify infections from blood samples. The study does not involve any experimental treatments or interventions and is designed to observe and collect data on the diagnostic process. No comparison groups or placebos are involved, as this is a diagnostic evaluation study. During the study, participants will have blood samples taken for NGS-based testing to detect infections. Researchers will measure how well the NGS method performs in diagnosing bloodstream infections and assess the average time taken to process these tests. Monitoring will include collecting clinical data and outcomes related to infection diagnosis. The total duration of participation varies, with data collected at baseline and throughout the patient's clinical course.
CONDITIONS
Brief Title
Next-Generation-Sequencing Approach to Neutropenic Sepsis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 65 18 years
- Able to provide informed consent
- Neutropenia defined as less than 500 ANC (Absolute Neutrophil Count)/�b5l or less than 1000 WBC (White Blood Cell Count)/�b5l if ANC is not available
- Fever or sepsis onset less than 24 hours prior
- Patients with life-threatening organ dysfunction caused by a dysregulated host response to a suspected or proven infection
You will not qualify if you...
- Age less than 18 years
- Refusal or inability to give informed consent without an acceptable patient representative
- Patients previously included who develop a new fever episode during the same hospitalization
- Imminent and inevitable death
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Baseline
Participants undergo next-generation sequencing to detect bloodstream infections using the DISQVER platform.
1 visit (in-person)
Trial Site Locations
Total: 6 locations
1
University Hospital of Cologne
Cologne, Germany
Actively Recruiting
2
Hospital Dessau
Dessau, Germany, 06847
Actively Recruiting
3
University Hospital of Essen
Essen, Germany, 45147
Actively Recruiting
4
University Hospital of Frankfurt
Frankfurt am Main, Germany, 60590
Actively Recruiting
5
University Hospital of Leipzig
Leipzig, Germany, 04103
Actively Recruiting
6
University Hospital of Magdeburg
Magdeburg, Germany, 39120
Actively Recruiting
Research Team
B
Boris Böll
J
Jorge Garcia Borrega
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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