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

Official title

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

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 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.

Primary outcome measures

• Number of patients colonized by ESBL-producing Enterobacterales and Carbapenem-resistant Enterobacterales (CRE) detected by rectal swab [Time frame: 90 days follow-up. In case of infection a security follow-up of 30 days will be performed]
• Number of Neutropenic fever (NF) and/or clinically relevant infection events caused by ESBL-producing Enterobacterales and CPE [Time frame: 90 days follow-up. In case of infection a security follow-up of 30 days will be performed]

Secondary outcome measures (7)

• All cause mortality at 30 and 90 days [Time frame: 90 day follow-up since inclusion]
• In case of infection, mortality related to the infection at day 30 and/or recurrence of infection until day 90 [Time frame: 90 days follow-up. In case of infection a security follow-up of 30 days will be performed]
• Length of hospitalisation(s) (in days) [Time frame: 90 days follow up since inclusion]
• Data collection on antibiotic usage in Days of treatment (DOT) [Time frame: 90 days follow-up. In case of infection a security follow-up of 30 days will be performed]
• Number of appropiate empirical and targeted treatment. [Time frame: 90 days follow-up. In case of infection a security follow-up of 30 days will be performed]
• C. difficile infection [Time frame: 90 days follow-up. In case of infection a security follow-up of 30 days will be performed]
• Number of fungal infections caused by yeast or mold [Time frame: 90 days follow-up. In case of infection a security follow-up of 30 days will be performed]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Spain · 15 centers

• Hospital Universitario Torrecárdenas — Almería
• Hospital Universitario De Jerez — Jerez de la Frontera
• Hospital Universitario de Vigo — Vigo
• Clinica Universidad de Navarra — Pamplona
• Hospital Universitario Vall d'Hebron — Barcelona
• Hospital Universitario Puerta del Mar — Cadiz
• Hospital Universitario Virgen de las Nieves Ruiz de Alda — Granada
• Hospital Universitario Juan Ramón Jiménez — Huelva
• … and 7 more centers

Identifiers

NCT: NCT07396571 · SCREEN-IN

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗