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

NCT07396571 | Not Yet Recruiting

• 1 other identifier: SCREEN-IN
• Study Type: observational
• Target: 535
• Locations: 1 country
• Sites: 15

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  Due to the observational nature of the study, all cases of NF or infection will be registered in the electronic case report form (eCRF)

  90 days follow-up. In case of infection a security follow-up of 30 days will be performed

Secondary Outcomes (7)

• All cause mortality at 30 and 90 days

  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

  90 days follow-up. In case of infection a security follow-up of 30 days will be performed

• Length of hospitalisation(s) (in days)

  90 days follow up since inclusion

• 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

• Number of appropiate empirical and targeted treatment.

  90 days follow-up. In case of infection a security follow-up of 30 days will be performed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Pública Andaluza para la gestión de la Investigación en Sevilla: lead

Study Sites (15)

Hospital Universitario Torrecárdenas

Almería, Andalusia, 04009, Spain

Location

Hospital Universitario De Jerez

Jerez de la Frontera, Cádiz, 11407, Spain

Location

Hospital Universitario de Vigo

Vigo, Galicia, 36310, Spain

Location

Clinica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

Location

Hospital Universitario Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Universitario Puerta del Mar

Cadiz, 11009, Spain

Location

Hospital Universitario Virgen de las Nieves Ruiz de Alda

Granada, 18014, Spain

Location

Hospital Universitario Juan Ramón Jiménez

Huelva, 21005, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Regional Universitario de Málaga

Málaga, 29010, Spain

Location

Hospital Clínico Universitario de Salamanca

Salamanca, 37007, Spain

Location

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

Location

Hospital Universitario Nuestra Señora de Valme

Seville, 41014, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

Microbiological isolates will be frozen and forwarded to the coordinating centre for Whole Genome Sequencing (WGS). These isolates shall be stored for a maximum period of 25 years

MeSH Terms

Conditions

Neutropenia

Condition Hierarchy (Ancestors)

Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Study Officials

• Zaira R. Palacios Baena, MD/PhD

  Virgen Macarena hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zaira Palacios Baena R. MD/PhD

CONTACT

0034 609320301; zaira.palacios.baena@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: February 9, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (15)