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

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Conditions studied: Hemato-oncologic Patients, Colonization, Neutropenia, Enterobacteria Non Susceptible to Carbapenem Carrier, ESBL-producing Enterobacteriaceae Infections

In brief

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.

Key facts

Study ID

NCT07396571

Run by

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

People needed

535

Starts

2026-02-01

Expected to finish

2028-12-01

Last updated by the study team

2026-03-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients admitted to Hematology departments with hematological diseases, including: myelodysplastic syndrome, acute myeloid leukemia, acute lymphoblastic leukemia, multiple myeloma, chronic lymphocytic leukemia, chronic myeloproliferative leukemias, lymphomas, or other hematological disorders.
• Patients scheduled to receive treatment for their underlying hematological disease, including myeloablative/cytotoxic chemotherapy, conditioning chemotherapy for hematopoietic stem cell transplantation (autologous, allogeneic, or other types), lymphodepleting chemotherapy for CAR-T cell therapy, and/or other treatments expected to induce neutropenia.
• Patients expected to develop neutropenia (neutrophil count < 0.5 \\times 10\^9/L, or < 1.0 \\times 10\^9/L when predicted to fall below 0.5 \\times 10\^9/L within the next 48 hours) in the coming days.
• Those who have signed the informed consent form.
• Participation in another study is permitted, provided it is observational and does not influence the potential colonization status.

You may not qualify if…

• Psychiatric disorder or inability to understand or follow the protocol instructions.
• Terminally ill patients or those with an estimated life expectancy of less than 30 days.
• Previous enrollment in the study.
• Known prior colonization by ESBL-producing Enterobacteriaceae (ESBL-E) or carbapenemase-producing Enterobacteriaceae (CPE).
• Physician's discretion: The patient's attending physician prefers not to include the patient in the study.

Where it is running

• Hospital Universitario Torrecárdenas — Almería, Andalusia, Spain
• Hospital Universitario De Jerez — Jerez de la Frontera, Cádiz, Spain
• Hospital Universitario de Vigo — Vigo, Galicia, Spain
• Clinica Universidad de Navarra — Pamplona, Navarre, Spain
• Hospital Universitario Vall d'Hebron — Barcelona, Spain
• Hospital Universitario Puerta del Mar — Cadiz, Spain
• Hospital Universitario Virgen de las Nieves Ruiz de Alda — Granada, Spain
• Hospital Universitario Juan Ramón Jiménez — Huelva, Spain
• Hospital Universitario Ramón y Cajal — Madrid, Spain
• Hospital Universitario La Paz — Madrid, Spain
• Hospital Regional Universitario de Málaga — Málaga, Spain
• Hospital Clínico Universitario de Salamanca — Salamanca, Spain
• Hospital Universitario Virgen Macarena — Seville, Spain
• Hospital Universitario Virgen del Rocío — Seville, Spain
• Hospital Universitario Nuestra Señora de Valme — Seville, Spain

Full record on ClinicalTrials.gov

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