Hemato-oncologic PatientsSCREEN-INNCT07396571
Predictive Score in Patients With Hematological Malignancies Colonized by Multidrug-resistant Enterobacteriaceae
An observational study of Hemato-oncologic Patients and Colonization, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 15 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemato-oncologic Patients, Colonization, Neutropenia
- How many people
- 535 participants
- Where
- 15 sitesSpain
- Study dates
- 4 Sep 2026to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
Spain15 sites
Hospital Universitario Torrecárdenas
Almería, Andalusia, 04009
Alexandra M. Aceituno Cano, 0034 950 01 60 00, alexandra.aceituno.sspa@juntadeandalucia.es
Hospital Universitario Vall d'Hebron
Barcelona, 08035
Adaia Albasanz Puig, 0034 675048317, adaia.albasanz@vallhebron.cat
Esther del Barrio Tofiño
Hospital Universitario Puerta del Mar
Cadiz, 11009
Jóse Ángel Raposo Puglia, MD, 0034 956002297, josegaleno.barrameda@gmail.com
Julia Morán Sánchez
Hospital Universitario Virgen de las Nieves Ruiz de Alda
Granada, 18014
Pedro González Sierra, MD, 0034 661470802, pedroa.gonzalez.sspa@juntadeandalucia.es
Claudia Mendoza López
Hospital Universitario Juan Ramón Jiménez
Huelva, 21005
Susana Ramírez García, 0034 959 01 60 00, susana84algamitas@hotmail.com
Francisco Javier Martínez Marcos
Hospital Universitario De Jerez
Jerez de la Frontera, Cádiz, 11407
Rubén Lobato Cano, MD, 0034 665 816 722, ruben.lobato27@gmail.com
María Vitoria Verdugo Cabeza de Vaca
Hospital Universitario Ramón y Cajal
Madrid, 28034
Esther Serrano-Conde Sánchez, 0034 618557775, esther.serranoconde@salud.madrid.org
Adrián Sánchez Tornero
Hospital Universitario La Paz
Madrid, 28046
Juan Carlos Ramos Ramos, 0034 618735476, juancarlos.ramos@salud.madrid.org
María Fátima López Fabal
Hospital Regional Universitario de Málaga
Málaga, 29010
Ignacio Márquez Gómez, MD, 0034 627333616, nachomarquezgomez@gmail.com
Francisco Javier Chamizo López
Clinica Universidad de Navarra
Pamplona, Navarre, 31008
José Luis Del Pozo León, 0034629559297, jdelpozo@unav.es
Sara Villar
Hospital Clínico Universitario de Salamanca
Salamanca, 37007
Alejandro Avendaño Pita, 0034 617695060, aavendano@saludcastillayleon.es
Lourdes Vázquez López
Hospital Universitario Virgen Macarena
Seville, 41009
Clara M. Rosso Fernandez, MD/PhD, 0034 955 01 21 44, claram.rosso.sspa@juntadeandalucia.es
Zaira R. Palacios Baena, MD/PhD, 0034609320301, zaira.palacios.baena@hotmail.com
Hospital Universitario Virgen del Rocío
Seville, 41013
Manuela Guilar Guisado, MD/PhD, 0034 670943816, maguilarguisado@yahoo.es
Adelina Gimeno Gascón
Hospital Universitario Nuestra Señora de Valme
Seville, 41014
Tania Arámbula Amaya, MD, 0034 652296157, tania_ivett@hotmail.com
Encarnación Gil Esparraga
Hospital Universitario de Vigo
Vigo, Galicia, 36310
Maria Teresa Pérez Rodríguez, MD, 0034626941726, perezrodriguezmt@gmail.com
Adrián Sousa Dominguez
About this study
Official title: 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:
Read more
- 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.
Read the 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.
- Conditions
- Hemato-oncologic Patients, Colonization, Neutropenia, Enterobacteria Non Susceptible to Carbapenem Carrier, ESBL-producing Enterobacteriaceae Infections
- Medical subject headings
- Neutropenia
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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
Mortality at 30-days after inclusion and mortality at 90-days after inclusion
Measured: 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
For patients with an infection episode, mortality related to the infection and recurrence will be assessed at day 30 of the security follow-up
Measured: In case of infection a security follow-up of 30 days will be performed
Length of hospitalisation(s) (in days)
Total number of hospitalisation days during the 90 day follow-up.
Measured: 90 days follow up since inclusion
Data collection on antibiotic usage in Days of treatment (DOT)
Data collection on antibiotic usage in days of treatment
Measured: 90 days follow-up. In case of infection a security follow-up of 30 days will be performed
Number of appropriate empirical and targeted treatment.
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.
Measured: 90 days follow-up. In case of infection a security follow-up of 30 days will be performed
C. difficile infection
Rate of patients presenting confirmed Clostridioses difficile toxin presence
Measured: 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
Proven, probable or possible fungal infection confirmed by growth of specimen in culture or fungal biomarkers.
Measured: 90 days follow-up. In case of infection a security follow-up of 30 days will be performed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start4 Sep 2026 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemato-oncologic PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 535 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zaira R. Palacios Baena, MD/PhD, Principal investigator, Virgen Macarena hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07396571
- Sponsor's protocol ID
- SCREEN-IN
- Acronym
- SCREEN-IN
- Status last verified
- Sep 2026
- First submitted
- 30 Jan 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Palacios-Baena ZR, Delgado-Valverde M, Caponcello MG, Olivares-Navarro P, Barrera-Pulido L, Madrigal MD, Flores R, Rodriguez-Fernandez A, Rubio-Martin E, Aleman-Rodriguez A, Jimenez-Jorge S, Rosso-Fernandez CM, Rodriguez-Bano J. Risk of colonisation and infection by extended-spectrum beta-lactamase-producing Enterobacterales and carbapenemase-producing Enterobacterales in patients with neutropenia: protocol for the SCREEN-IN multicentre prospective observational study. BMJ Open. 2026 Sep 24;16(9):e121248. doi: 10.1136/bmjopen-2026-121248.
PubMed 42785942
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Predictive Infection Score in Patients With Hematological Malignancies Colonized by Multidrug-resistant Enterobacteriaceae
- ClinicalTrials.gov ID
- NCT07396571
- Acronym / sponsor ID
- SCREEN-IN / SCREEN-IN
- Conditions
- Hemato-oncologic Patients, Colonization, Neutropenia, Enterobacteria Non Susceptible to Carbapenem Carrier, ESBL-producing Enterobacteriaceae Infections
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 535 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Study start
- 4 Sep 2026 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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)
7 secondary outcomes
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: 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 appropriate 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Derived from this study: PubMed 42785942Palacios-Baena ZR, Delgado-Valverde M, Caponcello MG, Olivares-Navarro P, Barrera-Pulido L, Madrigal MD, Flores R, Rodriguez-Fernandez A, Rubio-Martin E, Aleman-Rodriguez A, Jimenez-Jorge S, Rosso-Fernandez CM, Rodriguez-Bano J. Risk of colonisation and infection by extended-spectrum beta-lactamase-producing Enterobacterales and carbapenemase-producing Enterobacterales in patients with neutropenia: protocol for the SCREEN-IN multicentre prospective observational study. BMJ Open. 2026 Sep 24;16(9):e121248. doi: 10.1136/bmjopen-2026-121248.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zaira R. Palacios Baena, MD/PhD principal investigator
Virgen Macarena hospital
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemato-oncologic Patients and Colonization, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 15 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zaira Palacios Baena R. MD/PhD (0034 609320301, zaira.palacios.baena@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07396571, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026; AzTrials last refreshed its copy on 3 Nov 2026.