• Incidence and Risk Factors for Developing Infections in Patients Colonized by CP-KPC

  NCT05492539

  Unknown statusObservationalUpdated Feb 28, 2023
• European Prospective Cohort Study on Enterobacteriaceae Showing Resistance to Carbapenems

  NCT02709408

  CompletedObservationalUpdated Feb 21, 2021
• GRAM NEGATIVES STUDY

  NCT07749508

  RecruitingObservationalUpdated Aug 6, 2026
• Can the Relative Fecal Abundance of BLSE and the Digestive Microbiota be Predictive of the Risk of Infection in a Carrier Patient?

  NCT04699981

  Unknown statusInterventionalNot ApplicableUpdated Sep 13, 2023
• Prognostic Factors of Escherichia Coli Bloodstream Infections: Severity Score and Therapeutic Implications

  NCT02890901

  CompletedObservationalUpdated May 29, 2018
• Predictive Value of a Rectal Swab With Detection of Enterobacteria (ESBL-E), Carbapenemases, and High-level Cephalosporinase (HLC) on the Risk of Infections With C3G-resistant Enterobacteria

  NCT07345923

  RecruitingObservationalUpdated Jan 16, 2026

ClinicalTrials.gov ID

NCT07396571

Lead Sponsor

Fundación Pública Andaluza para la gestión de la Investigación en SevillaOTHER

Overall Status

Not yet recruiting

Study Type

Observational

Enrollment

535Estimated

Last Update Posted

Mar 2, 2026Actual

Start Date

Feb 2026Estimated

Primary Completion Date

May 2028Estimated

Completion Date

Dec 2028Estimated

Official Title

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

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.

• Hemato-oncologic Patients
• Colonization
• Neutropenia
• Enterobacteria Non Susceptible to Carbapenem Carrier
• ESBL-producing Enterobacteriaceae Infections

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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.

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

Fundación Pública Andaluza para la gestión de la Investigación en SevillaOTHER

perezrodriguezmt@gmail.com0034626941726

jdelpozo@unav.es0034629559297

adaia.albasanz@vallhebron.cat0034 675048317

josegaleno.barrameda@gmail.com0034 956002297

esther.serranoconde@salud.madrid.org0034 618557775

juancarlos.ramos@salud.madrid.org0034 618735476

claram.rosso.sspa@juntadeandalucia.es0034 955 01 21 44