Colonization, Enterobacteria Non Susceptible to Carbapenem Carrier, ESBL-producing Enterobacteriaceae Infections, Hemato-oncologic Patients, Neutropenia
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients colonized by ESBL-producing Enterobacterales and Carbapenem-resistant Enterobacterales (CRE) detected by rectal swab | 90 days follow-up. In case of infection a security follow-up of 30 days will be performed | 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 | 90 days follow-up. In case of infection a security follow-up of 30 days will be performed | Due to the observational nature of the study, all cases of NF or infection will be registered in the electronic case report form (eCRF) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All cause mortality at 30 and 90 days | 90 day follow-up since inclusion | 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 | In case of infection a security follow-up of 30 days will be performed | 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) | 90 days follow up since inclusion | Total number of hospitalisation days during the 90 day follow-up. |
| Data collection on antibiotic usage in Days of treatment (DOT) | 90 days follow-up. In case of infection a security follow-up of 30 days will be performed | Data collection on antibiotic usage in days of treatment |
| Number of appropriate empirical and targeted treatment. | 90 days follow-up. In case of infection a security follow-up of 30 days will be performed | Data will be obtained from the participant's clinical history. Appropriate treatment is defined as confirmed activity in vitro of the treatment against the infectious agent. |
| C. difficile infection | 90 days follow-up. In case of infection a security follow-up of 30 days will be performed | Rate of patients presenting confirmed Clostridioses difficile toxin presence |
| Number of fungal infections caused by yeast or mold | 90 days follow-up. In case of infection a security follow-up of 30 days will be performed | Proven, probable or possible fungal infection confirmed by growth of specimen in culture or fungal biomarkers. |
Countries
Spain
Contacts
CONTACTZaira Palacios Baena R. MD/PhD
PRINCIPAL_INVESTIGATORZaira R. Palacios Baena, MD/PhD
Virgen Macarena hospital
Outcome results
None listed