Clinical trial · Interventional
Prospective Study Evaluate the Timing of Empirical Treatment for Carbapenem-resistant Bacterials (CROEAT Study)
A Multi-center Single Arm Prospective Study in Patients of Hematological Malignancies Colonized With Carbapenem-resistant Bacterials to Evaluate the Timing of Empirical Antibiotic Treatment (CROEAT Study)
- 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)
In this study, we will evaluate the feasibility and clinical outcomes of risk adaptive empirical therapy to cover carbapenem resistance gram negative bacteria (CRO) in patients with hematological malignancies colonized with CRO. Patients assessed by the clinician as being at high risk for CRO infection and requiring intravenous antibiotics covering CRO must meet the following conditions: 1. Positive active screening for CRO or past CRO infection or local prevalence of CRO (e.g.,CRO detection rate\>20% among recently hospitalized patients); 2. Presence of fever or other possible signs and symptoms of infection; 3. Neutropenia(ANC\<0.1×10\^9/L)expected to last for ≥7 days,and having any of the following: * Gastrointestinal mucositis/peri-anal infection/intestinal obstruction; * Shock or severe sepsis; * Respiratory failure:deoxygenated PaO2\<60 mmHg or requiring mechanical ventilation; * Disseminated intravascular coagulation; * Altered mental status or psychiatric abnormalities; * Congestive heart failure requiring treatment; * Arrhythmia requiring treatment; * Recurrence of fever shortly after cessation of or during empirical treatment with carbapenems (≤7 days). The endpoints of study include incidence of blood-stream infection by CRO, incidence of all causes mortality, incidences of clinical and microbiology response.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carbapenem-resistant Enterobacterales | — | UNRESOLVED | — |
| Hematological Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Neutropenia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Empirical treatment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Study: empirical treatment
- description
- Empirical treatment to cover carbapenem-resistant enterobacterales
- interventionNames
- Other: Empirical treatment
Primary outcomes (1)
- measure
- Incidence of overall mortality
- timeFrame
- 14 days
- description
- Patients died of any causes
Secondary outcomes (3)
- measure
- Incidence of documented CRE blood stream infection
- timeFrame
- 30 days
- description
- Patients with positive culture of carbapenem-resistant enterobacterales
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria:
* Patients with hematological malignancies receiving hospital treatment such as chemotherapy/immunotherapy/hematopoietic stem cell transplantation;
* Those with a recent history of CRO colonization or who have been screened for CRO once a week continuously since admission;
* Patients assessed by the clinician as being at high risk for CRO infection and requiring intravenous antibiotics covering CRO must meet the following conditions:
1. Positive active screening for CRO or past CRO infection or local prevalence of CRO (e.g.,CRO detection rate\>20% among recently hospitalized patients);
2. Presence of fever or other possible signs and symptoms of infection;
3. Neutropenia(ANC\<0.1×10\^9/L)expected to last for ≥7 days,and having any of the following:
* Gastrointestinal mucositis/peri-anal infection/intestinal obstruction;
* Shock or severe sepsis;
* Respiratory failure:deoxygenated PaO2\<60 mmHg or requiring mechanical ventilation;
* Disseminated intravascular coagulation;
* Altered mental status or psychiatric abnormalities;
* Congestive heart failure requiring treatment;
* Arrhythmia requiring treatment;
* Recurrence of fever shortly after cessation of or during empirical treatment with carbapenems (≤7 days).
* The patient or their legal guardian has signed the informed consent form.
Exclusion Criteria:
* Pregnant or breastfeeding women;
* Individuals who are expected to die within 14 days of hospitalization or have an expected hospital stay of less than 7 days;
* Any conditions that the investigator believes may increase the risk to the patient;
* Severe psychological or psychiatric disorders with poor estimated compliance;
* The presence of any other conditions that the investigator deems unsuitable for participation in this study.References
Publications (0)
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