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

Recruitingn/aAges 18 Years - anyAllInstituto de Investigación Biomédica de Salamanca
NCT07277387 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 pre

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📋 Eligibility rules (as published)
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).
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What it tests

  • Plasma and DNA sample collection for proteomic and genomic analysis
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Where

3 sites
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Complejo Asistencial Universitario de Salamanca
Salamanca, Spain
Hospital Universitario Virgen Macarena
Seville, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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