An Observational, Practice based, Open label, Prospective Non Comparative, Multicenter, Post Marketing Surveillance Study to Assess Safety and Tolerability of Minocycline Hydrochloride 100 mg Intravenous (I.V.) Injection in Indian Patients with Multi-Drug Resistant Gram (MDR) Negative Bacterial Infections.
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- Cipla Ltd
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- 1.Adverse events and relevant abnormal laboratory findings (serious/non-serious, expected/unexpected, related/non-related)
研究概览
简要总结
This is an observational, practice-based, open-label, multicenter, post-marketing surveillance study. This study is to assess the safety and tolerability of minocycline hydrochloride 100 mg intravenous (I.V.) injection in Indian patients with multi-drug resistant gram (MDR) negative bacterial infections. Patients who are hospitalized with a confirmed MDR gram-negative bacterial infections will be enrolled in this study
The study duration will be at the discretion of the investigator.
Croissance Clinical Research is providing the Clinical Trial management Support to this clinical study.
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
- •Written signed and dated informed consent (patient or LAR)
- •Either gender with age 18 years and above
- •Patients with Multi-Drug Resistant (MDR) gram negative bacterial infection
- •Documented bacteriological infection susceptible to Minocycline Hydrochloride.
排除标准
- •Known hypersensitivity to Minocycline Hydrochloride or any of its components
- •Patient unsuitable to participate in the study as per the discretion of investigator
- •Pregnant or nursing females
- •Any other condition in the opinion of the investigator would affect the safety of the patient if Minocycline Hydrochloride is administered.
结局指标
主要结局
1.Adverse events and relevant abnormal laboratory findings (serious/non-serious, expected/unexpected, related/non-related)
时间窗: During Treatment period
2.Percentage of patients with adverse events
时间窗: During Treatment period
3.Treatment discontinuation rates
时间窗: During Treatment period
次要结局
- Not applicable(Not applicable)