Clinical trial · Observational
Plasma Host-Microbe Proteomics to Predict Complications in High-risk Febrile Neutropenia
A Multicenter Prospective Observational Study on the Plasma Proteomic Profiling of Human and Microbial Proteins for the Early Identification of Biomarker Combinations (Combitypes) Associated With Complications in Oncohematologic Patients With Febrile Neutropenia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Febrile neutropenia (FN) is a common oncologic emergency in patients with hematologic malignancies, associated with high morbidity and mortality. Early identification of patients at higher risk of complications such as sepsis or septic shock is critical to optimize antimicrobial management. This study aims to characterize the human and microbial plasma proteome using high-resolution mass spectrometry to identify biomarker combinations ("combitypes") capable of predicting complications in oncohematologic patients with FN. A cohort of 350 adult patients with high-risk FN and initially uncomplicated clinical presentation will be enrolled across three tertiary hospitals. Plasma samples will be collected at fever onset (before antibiotic initiation) and after 48 hours. Proteomic data will be integrated with clinical information using multivariate and machine learning models to develop a predictive model for complications.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Febrile Neutropenia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Plasma and DNA sample collection for proteomic and genomic analysis | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- High-risk FN cohort
- description
- Adult onco-hematologic inpatients meeting inclusion criteria; two plasma draws at fever onset and 48 h.
- interventionNames
- Biological: Plasma and DNA sample collection for proteomic and genomic analysis
Primary outcomes (1)
- measure
- Identification of plasma host-microbial proteomic signatures (combitypes) associated with major complications in febrile neutropenia.
- timeFrame
- Within 7 days from fever onset.
- description
- Evaluation of proteomic profiles (human and microbial) associated with hemodynamic instability, sepsis, septic shock, or death.
Secondary outcomes (5)
- measure
- Dynamic changes in plasma proteome over 48 hours
- timeFrame
- 0-48 hours
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adults (≥18 years). * Written informed consent provided by patient or legal representative. * Diagnosis of hematologic malignancy under induction chemotherapy, post-allogeneic hematopoietic stem cell transplantation, or CAR-T therapy. * High-risk febrile neutropenia (ANC ≤ 100 cells/mm³, expected duration ≥ 7 days, or significant comorbidities). * Fever defined as oral temperature ≥38.3 °C once or ≥38.0 °C for ≥1 hour. * Hospitalized or requiring immediate admission at the time of FN diagnosis. ´- Initial uncomplicated clinical presentation, with no previous infection or colonization by multidrug-resistant bacteria. * Eligible for initial monotherapy with broad-spectrum empirical antibiotic. * Availability for serial plasma sampling and clinical follow-up. Exclusion Criteria: * Age \<18 years. * Low-risk FN according to MASCC/CISNE criteria. * Initial sample collected after antibiotic administration. * Decline or inability to provide informed consent. * Any condition preventing safe participation or reliable sample collection. * Fever induced by noninfectious causes (considered as adjustment factor, not exclusion).
References
Publications (0)
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