An Observational, Multicentre, Prospective, Post Marketing Surveillance study to evaluate safety and efficacy of ELORESTM (Ceftriaxone, Sulbactam and Disodium Edetate) in patients with various bacterial infections (Labeled indications).
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 2,500
- 试验地点
- 17
- 主要终点
- To obtain safety information on the use of ELORESTM in patients with various bacterial infections
研究概览
简要总结
Study Title : - An Observational, Multicenter, Prospective, Post Marketing Surveillance study (P.M.S) to evaluate safety and efficacy of ELORESTM(Ceftriaxone+ Sulbactam+ Disodium Edetate) in patients with various bacterial infections (Labeled indications) Primary Objective : - To obtain safety information on the use of ELORESTM (Ceftriaxone + Sulbactam + Disodium Edetate) in patients with various bacterial infections (Labeled indications). Secondary Objective : - To monitor the therapeutic outcome of ELORESTM (Ceftriaxone + Sulbactam + Disodium Edetate) in subjects with various bacterial infections (Labeled indications). Primary Endpoints: Incidence of adverse events (AEs) and incidence of discontinuation due to AEs
Secondary Endpoints: Observe of Clinical Cure rate at the end of treatment
Study Design : - An observational multicenter, prospective, post marketing surveillance study Study Duration : - 06 months (or as per sponsor’s discretion)
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 1.00 Day(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Eligibility Criteria:
- •Patients with a suspected or confirmed diagnosis of bacterial infection (labelled indications)
- •Patients who receive a prescription of ELORES according to the indication stated in the local approved SmPC [Lower Respiratory Tract Infections, Urinary Tract Infections (complicated and uncomplicated), Bacterial Septicaemia, Chronic Suppurative Otitis Media, Infections of Bones and Joints, Infections of Skin and Soft Tissues, Surgical Prophylaxis (including pre and postsurgical infections)]
- •Written informed consent signed by the patient or legally acceptable representative(s) in line with applicable regulation of country.
- •Planned treatment in line with the Summary of Product Characteristics, i.e. exclusion of all patients with contraindications.
排除标准
- •No Exclusion criteria in view of Non-Interventional Observational PMS study.
结局指标
主要结局
To obtain safety information on the use of ELORESTM in patients with various bacterial infections
时间窗: 10 days
次要结局
- To monitor the therapeutic outcome of ELORESTM (Ceftriaxone + Sulbactam + Disodium Edetate) in subjects with various bacterial infections (Labeled indications).(Observe of Clinical Cure rate at the end of treatment)