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NOT YET RECRUITING
NCT07047352
NA

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

Sponsor: Shanghai Jiao Tong University School of Medicine

View on ClinicalTrials.gov

Summary

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

91

Start Date

2025-08-01

Completion Date

2026-06-30

Last Updated

2025-07-02

Healthy Volunteers

No

Interventions

OTHER

Empirical treatment

Empirical treatment to cover carbapenem-resistant enterobacterales

Locations (1)

Rui Jin Hospital

Shanghai, Shanghai Municipality, China