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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, prospective observational study enrolling adults with high-risk febrile neutropenia due to hematologic malignancies. Plasma samples are collected at fever onset before antibiotics and again at 48 hours, then analyzed with high-resolution mass spectrometry to measure host and microbial proteins. Data will be integrated with clinical information using multivariate and machine learning methods to build a predictive model for complications such as sepsis or septic shock. The goal is to identify biomarker patterns, or combitypes, that distinguish patients at higher risk for poor outcomes beyond current markers like CRP or procalcitonin. A subset of patients will have targeted validation to confirm the proteomic findings.

Why it matters

Who can join: the full rules

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).

Where it's running

• Complejo Asistencial Universitario de Salamanca
  Salamanca, Salamanca, Spain Recruiting
• Hospital Universitari Vall d'Hebron
  Barcelona, Barcelona, Spain Not yet recruiting
• Hospital Universitario Virgen Macarena
  Seville, Sevilla, Spain Not yet recruiting

Study contacts

• Principal investigator: Jesús Francisco Bermejo Martín, MD PhD — Centro Asistencial Universitario de Salamanca (CAUSA)
• Study coordinator: Jesús Francisco Bermejo Martín, MD PhD
• Email: jfbermejo@usal.es
• Phone: +34923 29 45 41

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.