Prospective Study Evaluate the Timing of Empirical Treatment for Carbapenem-resistant Bacterials (CROEAT Study)

Launched by SHANGHAI JIAO TONG UNIVERSITY SCHOOL OF MEDICINE · Jun 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to treat infections caused by a type of bacteria called carbapenem-resistant Enterobacterales (CRO), which are hard to treat with common antibiotics. The study focuses on patients with blood cancers who have a low number of white blood cells (a condition called neutropenia) and who are at high risk of having these tough infections. Researchers want to see if starting antibiotics that specifically target CRO bacteria early on, based on a patient’s risk, can improve outcomes like preventing bloodstream infections and reducing deaths.

Patients who might join this study are adults with blood cancers receiving treatments like chemotherapy or stem cell transplants. They must have signs of infection, such as fever, and a very low white blood cell count expected to last at least a week. They also need to have tested positive for CRO bacteria recently or come from a hospital area where these bacteria are common. During the study, participants will be carefully monitored to see how well the treatment works and if it helps control the infection. It’s important to note that pregnant women, those expected to have a very short hospital stay, or people with certain health or mental conditions may not be eligible. If you or a loved one fits this description and are interested, your doctor can provide more details about the study and what participation would involve.

Gender

ALL

Eligibility criteria

• 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.