Clinical trial · Observational
Predictive Score in Patients With Hematological Malignancies Colonized by Multidrug-resistant Enterobacteriaceae
Development of a Predictive Infection Score in Patients With Hematological Malignancies Colonized by Multidrug-resistant Enterobacteriaceae
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colonization | — | UNRESOLVED | — |
| Enterobacteria Non Susceptible to Carbapenem Carrier | — | UNRESOLVED | — |
| ESBL-producing Enterobacteriaceae Infections | — | UNRESOLVED | — |
| Hemato-oncologic Patients | — | UNRESOLVED | — |
| Neutropenia | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Number of patients colonized by ESBL-producing Enterobacterales and Carbapenem-resistant Enterobacterales (CRE) detected by rectal swab
- timeFrame
- 90 days follow-up. In case of infection a security follow-up of 30 days will be performed
- description
- A weekly control of colonizations status will be performed via rectal swabs, while the patient is hospitalized.
- measure
- Number of Neutropenic fever (NF) and/or clinically relevant infection events caused by ESBL-producing Enterobacterales and CPE
- timeFrame
- 90 days follow-up. In case of infection a security follow-up of 30 days will be performed
- description
- Due to the observational nature of the study, all cases of NF or infection will be registered in the electronic case report form (eCRF)
Secondary outcomes (7)
- measure
- All cause mortality at 30 and 90 days
- timeFrame
- 90 day follow-up since inclusion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available