NCT07396571

Predictive Score in Patients With Hematological Malignancies Colonized by Multidrug-resistant Enterobacteriaceae

Development of a Predictive Infection Score in Patients With Hematological Malignancies Colonized by Multidrug-resistant Enterobacteriaceae

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 535 (estimated)
• Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goals of this observational study are to identify risk factors for ESBL-producing Enterobacterales and carbapenemase-producing Enterobacterales (CPE) colonization in oncohematological patients with severe neutropenia, and to develop and validate a predictive model of infection caused by ESBL-producing Enterobacterales and CPE in patients previously colonized by the same bacteria. The main questions the study aims to answer are: * What are the risk factors for ESBL-producing Enterobacterales and CPE colonization in patients with severe neutropenia? * Can a predictive model be developed to accurately predict infections in the colonized patients? Study Design \& Participants: Participants will be screened after receiving neutropenia-inducing treatment (e.g., chemotherapy, chimeric antigen receptor T-cell (CAR-T) therapy, or others). A baseline rectal swab will be collected to assess initial colonization status, followed by weekly swabs throughout the duration of neutropenia. Patients will be followed for 90 days from initial screening, during which the study team will record any infections, with an additional 30-day follow-up period. All hospitalization data will be recorded.

Detailed description

An exploratory metagenomics sub-study will be conducted within the study. Its goal is to describe the intestinal microbiome in patients and analyze any correlation between the microbiome and infection and mortality. For logistical reasons, this sub-study will be performed only on patients in the Seville area. This analysis will be performed via sequencing of the 16S ribosomal ribonucleic acid (rRNA) gene.

Conditions

• Hemato-oncologic Patients
• Colonization
• Neutropenia
• Enterobacteria Non Susceptible to Carbapenem Carrier
• ESBL-producing Enterobacteriaceae Infections

Timeline

• Start date: 2026-02-01
• Primary completion: 2028-05-01
• Completion: 2028-12-01
• First posted: 2026-02-09
• Last updated: 2026-03-02

Locations

15 sites across 1 country: Spain