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.
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.
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).
Patients 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.
Cohort
Prospective
Not listed
Number of patients colonized by ESBL-producing Enterobacterales and Carbapenem-resistant Enterobacterales (CRE) detected by rectal swab
A weekly control of colonizations status will be performed via rectal swabs, while the patient is hospitalized.
Number of Neutropenic fever (NF) and/or clinically relevant infection events caused by ESBL-producing Enterobacterales and CPE
Due to the observational nature of the study, all cases of NF or infection will be registered in the electronic case report form (eCRF)
All cause mortality at 30 and 90 days
Mortality at 30-days after inclusion and mortality at 90-days after inclusion
In case of infection, mortality related to the infection at day 30 and/or recurrence of infection until day 90
For patients with an infection episode, mortality related to the infection and recurrence will be assessed at day 30 of the security follow-up
Length of hospitalisation(s) (in days)
Total number of hospitalisation days during the 90 day follow-up.
Data collection on antibiotic usage in Days of treatment (DOT)
Data collection on antibiotic usage in days of treatment
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