NCT07277387 Plasma Host-Microbe Proteomics to Predict Complications in High-risk Febrile Neutropenia
| NCT ID | NCT07277387 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Instituto de Investigación Biomédica de Salamanca |
| Condition | Febrile Neutropenia |
| Study Type | OBSERVATIONAL |
| Enrollment | 350 participants |
| Start Date | 2026-06-09 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 350 participants in total. It began in 2026-06-09 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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).
Contact & Investigator
Jesús Francisco Bermejo Martín, MD PhD
PRINCIPAL INVESTIGATOR
Centro Asistencial Universitario de Salamanca (CAUSA)
Frequently Asked Questions
Who can join the NCT07277387 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Febrile Neutropenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07277387 currently recruiting?
Yes, NCT07277387 is actively recruiting participants. Contact the research team at jfbermejo@usal.es for enrollment information.
Where is the NCT07277387 trial being conducted?
This trial is being conducted at Barcelona, Spain, Salamanca, Spain, Seville, Spain.
Who is sponsoring the NCT07277387 clinical trial?
NCT07277387 is sponsored by Instituto de Investigación Biomédica de Salamanca. The principal investigator is Jesús Francisco Bermejo Martín, MD PhD at Centro Asistencial Universitario de Salamanca (CAUSA). The trial plans to enroll 350 participants.