Using next-generation sequencing to detect infections in neutropenic patients with fever
Next-Generation-Sequencing Approach to Neutropenic Sepsis
This study is testing a new method using advanced DNA technology to see if it can help doctors quickly find infections in patients with low white blood cell counts and fever.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital of Cologne Academic / other |
| Locations | 6 sites (Cologne and 5 other locations) |
| Trial ID | NCT05815628 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of the DISQVER platform, which utilizes next-generation sequencing (NGS), for diagnosing bloodstream infections in patients experiencing febrile neutropenia. It is a multi-centre study that will gather data from various hospitals to assess the diagnostic capabilities of this innovative approach. By focusing on neutropenic patients with fever or sepsis, the study seeks to provide valuable insights into the timely identification of infections in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are experiencing febrile neutropenia and can provide informed consent.
Not a fit: Patients under 18 years old or those who are unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to faster and more accurate diagnosis of infections in neutropenic patients, potentially improving patient outcomes.
How similar studies have performed: Other studies utilizing next-generation sequencing for infection detection have shown promising results, indicating that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cologne and 5 other locations
- University Hospital of Cologne — Cologne, Germany (Recruiting)
- Hospital Dessau — Dessau, Germany (Recruiting)
- University Hospital of Essen — Essen, Germany (Recruiting)
- University Hospital of Frankfurt — Frankfurt am Main, Germany (Recruiting)
- University Hospital of Leipzig — Leipzig, Germany (Recruiting)
- University Hospital of Magdeburg — Magdeburg, Germany (Recruiting)
Study contacts
- Study coordinator: Boris Böll
- Email: boris.boell@uk-koeln.de
- Phone: +4922147842579
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.