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

NCT07277387 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 350

Last updated 2026-04-23

No results posted yet for this 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.

Conditions

Interventions

BIOLOGICAL

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.

Sponsors & Collaborators

  • Instituto de Investigación Biomédica de Salamanca

    lead OTHER

Principal Investigators

  • Jesús Francisco Bermejo Martín, MD PhD · Centro Asistencial Universitario de Salamanca (CAUSA)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-15
Primary Completion
2028-12-31
Completion
2029-01-31

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07277387 on ClinicalTrials.gov