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

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.

NCT Number	NCT07047352
Lead Sponsor	Shanghai Jiao Tong University School of Medicine
Conditions	Carbapenem-resistant Enterobacterales, Neutropenia, Hematological Malignancies
Enrollment	91 participants
Start Date	2025-08-01
Primary Completion	2025-12-31 (estimated)
Study Completion	2026-06-30 (estimated)
Updated on ClinicalTrials.gov	2025-07-02