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

Study acronym: SCREEN-IN
StatusNot Yet Recruiting
PhaseNot specified
Started2026-09-04
View on ClinicalTrials.gov ↗

Amendment history

2026-09-01
Study Status, Outcome Measures v2
Start date2026-02→2026-09-04
Secondary endpoints7 entries, revised
Number of appropiateappropriate empirical and targeted treatment.
2026-02-27
Study Status, Study Description, Outcome Measures v1
Secondary endpoints7 entries, revised
All cause mortality at 30 and 12090 days In case of infection, mortality related to the infection at day 30 and/or recurrence of infection until day 12090 AdjustmentNumber of appropiate empirical orand targeted treatment. Number forof fungal infections with a confirmed etiological diagnosis Fungal infection caused by yeast or mold
Primary endpoints2 entries, revised
Number of Neutropenic fever (NF) and/or clinically relevant infection events caused by ESBL-producing Enterobacterales and CPE Number of patients colonized by ESBL-producing Enterobacterales and Carbapenem-resistant Enterobacterales (CRE) colonization in oncohematological patients detected by rectal swab Neutropenic fever (NF) and/or clinically relevant infection caused by ESBL-producing Enterobacterales and CPE
2026-01-30
Original filing
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.
Trial Details
NCT Number NCT07396571
Lead Sponsor Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Conditions Hemato-oncologic Patients, Colonization, Neutropenia, Enterobacteria Non Susceptible to Carbapenem Carrier, ESBL-producing Enterobacteriaceae Infections
Enrollment 535 participants
Start Date 2026-09-04
Primary Completion 2028-05 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-09-03