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Plasma Host-Microbe Proteomics to Predict Complications in High-risk Febrile Neutropenia
Sponsor: Instituto de Investigación Biomédica de Salamanca
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
350
Start Date
2026-01
Completion Date
2029-01
Last Updated
2025-12-11
Healthy Volunteers
No
Conditions
Interventions
Plasma and DNA sample collection for proteomic and genomic analysis
Collection of 10 mL of peripheral blood in EDTA tubes at fever onset (before antibiotic initiation) and 48 hours later for proteomic and genomic analysis. Samples are processed to obtain plasma and DNA, which will be used for mass spectrometry-based proteomics and potential metagenomic studies.
Locations (3)
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona, Spain
Complejo Asistencial Universitario de Salamanca
Salamanca, Salamanca, Spain
Hospital Universitario Virgen Macarena
Seville, Sevilla, Spain