CTRI/2013/06/003761招募中4 期
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
- 4 期
- 状态
- 招募中
- 入组人数
- 2,500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •Eligibility Criteria:
- •1. Patients with a suspected or confirmed diagnosis of bacterial infection (labelled indications)
- •2. 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)]
- •3. Written informed consent signed by the patient or legally acceptable representative(s) in line
- •with applicable regulation of country.
- •4. 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.
研究者
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