Predictive Score in Patients With Hematological Malignancies Colonized by Multidrug-resistant Enterobacteriaceae (SCREEN-IN)

February 27, 2026 updated by: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

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

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.

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

535

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall d'Hebron
        • Contact:
        • Sub-Investigator:
          • Esther del Barrio Tofiño
        • Sub-Investigator:
          • Laura Fox
      • Cadiz, Spain, 11009
        • Hospital Universitario Puerta Del Mar
        • Contact:
        • Sub-Investigator:
          • Julia Morán Sánchez
        • Sub-Investigator:
          • Fernando Delgado Hidalgo
        • Sub-Investigator:
          • Fátima Galán
        • Sub-Investigator:
          • Isabel María Rodríguez Serván
      • Granada, Spain, 18014
        • Hospital Universitario Virgen de las Nieves Ruiz de Alda
        • Contact:
        • Sub-Investigator:
          • Claudia Mendoza López
        • Sub-Investigator:
          • Carmen Hidalgo Tenorio
      • Huelva, Spain, 21005
        • Hospital Universitario Juan Ramón Jiménez
        • Contact:
        • Sub-Investigator:
          • Francisco Javier Martínez Marcos
        • Sub-Investigator:
          • Francisco Franco Álvarez de Luna
      • Madrid, Spain, 28034
        • Hospital Universitario Ramón y Cajal
        • Contact:
        • Sub-Investigator:
          • Adrián Sánchez Tornero
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
        • Contact:
        • Sub-Investigator:
          • María Fátima López Fabal
        • Sub-Investigator:
          • Silvia García Bujalance
        • Principal Investigator:
          • Karem Kumala
      • Málaga, Spain, 29010
        • Hospital Regional Universitario de Malaga
        • Contact:
        • Sub-Investigator:
          • Francisco Javier Chamizo López
        • Sub-Investigator:
          • María Dolores Rojo Martín
        • Sub-Investigator:
          • María Ángeles Cuesta Casas
        • Sub-Investigator:
          • Daniel Barrios Decoud
      • Salamanca, Spain, 37007
        • Hospital Clinico Universitario de Salamanca
        • Contact:
        • Sub-Investigator:
          • Lourdes Vázquez López
        • Sub-Investigator:
          • Juan Luis Muñoz Bellido
      • Seville, Spain, 41013
        • Hospital Universitario Virgen del Rocio
        • Contact:
        • Sub-Investigator:
          • Adelina Gimeno Gascón
      • Seville, Spain, 41014
        • Hospital Universitario Nuestra Senora De Valme
        • Contact:
        • Sub-Investigator:
          • Encarnación Gil Esparraga
        • Sub-Investigator:
          • Adriana Márquez Sanabria
      • Seville, Spain, 41009
        • Hospital Universitario Virgen Macarena
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Elena Rubio Martín
        • Sub-Investigator:
          • Aurora Alemán Rodríguez
        • Sub-Investigator:
          • Maria Giulia Caponcello
        • Sub-Investigator:
          • Rafael Flores Cornejo
        • Sub-Investigator:
          • M. Dolores Madrigal Toscano
        • Sub-Investigator:
          • María de la Haba González
        • Sub-Investigator:
          • Jesús Rodríguez Baño
        • Sub-Investigator:
          • Mercedes Delgado Valverde
        • Sub-Investigator:
          • Patricia Pérez Palacios
        • Sub-Investigator:
          • Paula Olivares Navarro
        • Sub-Investigator:
          • Lola Cubero Aranda
    • Andalusia
    • Cádiz
      • Jerez de la Frontera, Cádiz, Spain, 11407
        • Hospital Universitario de Jerez
        • Contact:
        • Sub-Investigator:
          • María Vitoria Verdugo Cabeza de Vaca
        • Sub-Investigator:
          • María Carmen Gómez Sánchez
        • Sub-Investigator:
          • Marina Murillo Pineda
    • Galicia
      • Vigo, Galicia, Spain, 36310
        • Hospital Universitario de Vigo
        • Contact:
        • Sub-Investigator:
          • Adrián Sousa Dominguez
        • Sub-Investigator:
          • Irene Figueroa Parada
        • Sub-Investigator:
          • Francisco J Vasallo Vidal
        • Sub-Investigator:
          • Alejandro Araujo Ameijeiras
        • Sub-Investigator:
          • Claudia Vázquez Estévez
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Clinica Universidad de Navarra
        • Contact:
        • Sub-Investigator:
          • Sara Villar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: 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)
90 days follow-up. In case of infection a security follow-up of 30 days will be performed

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All cause mortality at 30 and 90 days
Time Frame: 90 day follow-up since inclusion
Mortality at 30-days after inclusion and mortality at 90-days after inclusion
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
For patients with an infection episode, mortality related to the infection and recurrence will be assessed at day 30 of the security follow-up
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
Total number of hospitalisation days during the 90 day follow-up.
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
Data collection on antibiotic usage in days of treatment
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
Data will be obtained from the participat's clinical history. Appropriate treatment is defined as confirmed activity in vitro of the treatment against the infectious agent.
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
Rate of patients presenting confirmed Clostridioses difficile toxin presence
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
Proven, probable or possible fungal infection confirmed by growth of specimen in culture or fungal biomarkers.
90 days follow-up. In case of infection a security follow-up of 30 days will be performed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Investigators

  • Principal Investigator: Zaira R. Palacios Baena, MD/PhD, Virgen Macarena Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

January 30, 2026

First Submitted That Met QC Criteria

January 30, 2026

First Posted (Actual)

February 9, 2026

Study Record Updates

Last Update Posted (Actual)

March 2, 2026

Last Update Submitted That Met QC Criteria

February 27, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCREEN-IN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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