Plasma Host-Microbe Proteomics to Predict Complications in High-risk Febrile Neutropenia (NCT07277387) | Clinical Trial Compass
RecruitingNot Applicable
Plasma Host-Microbe Proteomics to Predict Complications in High-risk Febrile Neutropenia
Spain350 participantsStarted 2026-06-09
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Identification of plasma host-microbial proteomic signatures (combitypes) associated with major complications in febrile neutropenia.
Timeframe: Within 7 days from fever onset.
Trial details
NCT IDNCT07277387
SponsorInstituto de Investigación Biomédica de Salamanca