An observational study in Hemato-oncologic Patients, Colonization and Neutropenia, sponsored by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla. Not yet recruiting at 15 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Observational
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:
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.
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.
316 studies on the registry are indexed under Neutropenia; 42 are open to participants now.
This study's planned enrollment of 535 is above the median of 203 across 59 observational studies indexed under Neutropenia.
Browse Neutropenia studies →Fundación Pública Andaluza para la gestión de la Investigación en Sevilla is the lead sponsor of 120 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Time frame: 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)
Time frame: 90 days follow-up. In case of infection a security follow-up of 30 days will be performed
All cause mortality at 30 and 90 days
Mortality at 30-days after inclusion and mortality at 90-days after inclusion
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
For patients with an infection episode, mortality related to the infection and recurrence will be assessed at day 30 of the security follow-up
Time frame: 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.
Time frame: 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
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.
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.
Time frame: 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
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
Proven, probable or possible fungal infection confirmed by growth of specimen in culture or fungal biomarkers.
Time frame: 90 days follow-up. In case of infection a security follow-up of 30 days will be performed
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for May 2028, 20 months later.
Of 23 observational studies under Neutropenia, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 190. This study's planned 20 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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