Plasma Host-Microbe Proteomics to Predict Complications in High-risk Febrile Neutropenia

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Identification of plasma host-microbial proteomic signatures (combitypes) associated with major complications in febrile neutropenia. — Within 7 days from fever onset.
  Evaluation of proteomic profiles (human and microbial) associated with hemodynamic instability, sepsis, septic shock, or death.

Trial sites (3)

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