Febrile NeutropeniaNEXUSNCT05815628
Next-Generation-Sequencing Approach to Neutropenic Sepsis
An observational study of Febrile Neutropenia, run by Boris Böll at 6 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Febrile Neutropenia
- What is being tested?
- DISQVER
- How many people
- 400 participants
- Where
- 6 sitesGermany
- Study dates
- 5 Jun 2024to 1 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 400 neutropenic patients with febrile neutropenia
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Germany6 sites, 6 recruiting
- Recruiting
University Hospital of Cologne
Cologne
Boris Böll, Prof. Dr.
- Recruiting
Hospital Dessau
Dessau, 06847
Behre, +493405011275, gerhard.behre@klinikum-dessau.de
- Recruiting
University Hospital of Essen
Essen, 45147
Liebregts, +4917663402272, tobias.liebregts@uk-essen.de
- Recruiting
University Hospital of Frankfurt
Frankfurt am Main, 60590
Vehreschild, +496963015452, maria.vehreschild@ukffm.de
- Recruiting
University Hospital of Leipzig
Leipzig, 04103
Trawinski, +493419724970, henning.trawinski@medizin.uni-leipzig.de
- Recruiting
University Hospital of Magdeburg
Magdeburg, 39120
Schalk, +493916725556, enrico.schalk@med.ovgu.de
About this study
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.
Read the 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.
- Conditions
- Febrile Neutropenia
- Being tested
- DISQVER
- Medical subject headings
- Febrile Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DISQVERDiagnostic test
NGS based infection diagnosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the performance of a NGS-based
Number of Participants with detection of pathogen
Measured: Baseline
Secondary outcomes (1)
Average process time for NGS-based measurements
Timeframe of sampling to result of NGS-based sampling
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start5 Jun 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Febrile NeutropeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boris Böll
- Sponsor type
- University, hospital or other
- Collaborators
- Noscendo GmbH
- Responsible party
- Sponsor-investigator, Boris Böll, University Hospital of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05815628
- Sponsor's protocol ID
- NEXUS-5058
- Acronym
- NEXUS
- Status last verified
- Aug 2025
- First submitted
- 9 Mar 2023
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Next-Generation-Sequencing Approach to Neutropenic Sepsis
- ClinicalTrials.gov ID
- NCT05815628
- Acronym / sponsor ID
- NEXUS / NEXUS-5058
- Conditions
- Febrile Neutropenia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Boris BöllUniversity, hospital or other
- Collaborators
- Noscendo GmbH
- Study start
- 5 Jun 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 400 neutropenic patients with febrile neutropenia
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DISQVERNGS based infection diagnosis | Diagnostic test | – |
Primary outcome
Evaluation of the performance of a NGS-based
Time frame: Baseline
Number of Participants with detection of pathogen
1 secondary outcome
Average process time for NGS-based measurements
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Febrile Neutropenia, run by Boris Böll at 6 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Boris Böll (+4922147842579, boris.boell@uk-koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the performance of a NGS-based (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.