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

N/ANot Yet RecruitingNCT07396571

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla535 enrolled

Overview

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 120 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.

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.

Study Type

OBSERVATIONAL

Enrollment

535

Conditions

Hemato-oncologic Patients Colonization Neutropenia

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria * 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. Exclusion criteria * 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.

Locations (15)

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

...and 5 more locations

Outcomes

Primary Outcomes

ESBL-producing Enterobacterales and Carbapenem-resistant Enterobacterales (CRE) colonization in oncohematological patients detected by rectal swab

A weekly control of colonizations status will be performed via rectal swabs, while the patient is hospitalized.

Time frame: 120 days follow-up. In case of infection a security follow-up of 30 days will be performed

Neutropenic fever (NF) and/or clinically relevant infection 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)

Time frame: 120 days follow-up. In case of infection a security follow-up of 30 days will be performed

Secondary Outcomes

All cause mortality at 30 and 120 days

Mortality at 30-days after inclusion and mortality at 120-days after inclusion

Time frame: 120 day follow-up since inclusion

In case of infection, mortality related to the infection at day 30 and/or recurrence of infection until day 120

For patients with an infection episode, mortality related to the infection and recurrence will be assessed at day 30 of the security follow-up

Time frame: 120 days follow-up. In case of infection a security follow-up of 30 days will be performed

Length of hospitalisation(s) (in days)

Total number of hospitalisation days during the 120 day follow-up.

Time frame: 120 days follow up since inclusion

Data collection on antibiotic usage in Days of treatment (DOT)

Data collection on antibiotic usage in days of treatment

Time frame: 120 days follow-up. In case of infection a security follow-up of 30 days will be performed

Adjustment of empirical or targeted treatment for infections with a confirmed etiological diagnosis

Data collection of antibiotic treatment changes from empirical to targeted based on microbiological results.

Time frame: 120 days follow-up. In case of infection a security follow-up of 30 days will be performed

C. difficile infection

Rate of patients presenting confirmed Clostridioses difficile toxin presence

Time frame: 120 days follow-up. In case of infection a security follow-up of 30 days will be performed

Fungal infection caused by yeast or mold

Proven, probable or possible fungal infection confirmed by growth of specimen in culture or fungal biomarkers.

Time frame: 120 days follow-up. In case of infection a security follow-up of 30 days will be performed

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

Overview

Conditions

Eligibility

Locations (15)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts