A prospective, observational, multi-center real world study to evaluate the effectiveness and safety of ELORES (Ceftriaxone plus Sulbactam plus Disodium Edetate) in patients with carbapenem resistant gram-negative infections caused by Enterobacteriaceae (Escherichia coli, Klebsiella pneumoniae) and Acinetobacter baumannii.

Cipla Ltd11 个研究点分布在 1 个国家目标入组 200 人开始时间: 2025年3月31日最近更新: 2026年1月2日

试验速览

阶段: Unknown
状态: 招募中
发起方: Cipla Ltd
入组人数: 200
试验地点: 11
主要终点: Effectiveness Endpoints:

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a prospective, observational, multi-center real world study to evaluate the effectiveness and safety of ELORES (Ceftriaxone + Sulbactam + Disodium Edetate) in patients with carbapenem resistant gram-negative infections caused by Enterobacteriaceae (Escherichia coli, Klebsiella pneumoniae) and Acinetobacter baumannii.

研究设计

研究类型: Observational

入排标准

年龄范围: 18.00 Year(s) 至 99.00 Year(s)（—）
性别: All

入选标准

•All adult patients (more than or equal to 18 years of age) with carbapenem resistant gram-negative infections (suspected or proven) such as ventilator associated pneumonia (VAP), hospital acquired pneumonia (HAP), complicated urinary tract infection (cUTI), skin and soft tissue infection (SSTI) bloodstream infection (BSI) and eligible to receive ELORES as per prescribing information at discretion of Investigator
•Patient is eligible to receive ELORES at least for 5 days at the discretion of the investigator.
•Patient or their legally acceptable representatives who voluntarily provide written informed consent.

排除标准

•Hypersensitivity to ceftriaxone or salbactum or disodium edetate or their excipients or drugs used in the study or any beta lactam antibiotic 2.Patients receiving intravenous calcium treatment 3.Pregnant or breastfeeding women 4.Renal insufficiency with creatinine clearance less than 30 mL per hr.