A Phase IV Pharmacovigilance, Post-Authorization Clinical Trial To Evaluate And Assess The Safety Of Tigecycline In The Approved Indications In The Usual Health Care Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 115
- 主要终点
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
This is a study to evaluate the safety of tigecycline in patients with complicated intra-abdominal infections (cIAI) and complicated skin and soft tissue infections (cSSTI) under real practice in the usual hospital setting and patients' conditions, in order to assess the "real incidence" of adverse events related with tigecycline in these patients.
详细描述
Since around 50 patients were included in Spanish centers involved in the Phase III Tygacil clinical development program, and on the basis of the recruitment capacity of the centers within the predefined time window and the number of patients consenting to be enrolled in the study, the total number of patients estimated to be enrolled in the study is 500. With this sample size, it will be possible to obtain precise estimations of the incidence of particular types of adverse events.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent signed by patients prior to this study entry.
- •18 years of age or older at the screening visit.
- •Patients with cIAI or cSSTI.
- •Patients who are going to or have just been given in the previous 48 hours at least a dose of tigecycline to treat any of the above infections.
- •In the opinion of the investigator, the patient will be able to comply with the requirements of the protocol.
排除标准
- •Known hypersensibility to tigecycline.
- •Females who are pregnant, breast feeding, or at risk of pregnancy and not using a medically acceptable form of contraception.
- •Use any investigational drug within four weeks of the screening visit.
- •Uncooperative patients or a history of poor compliance.
研究组 & 干预措施
1
Patients hospitalized because of cIAI or cSSTI
干预措施: Tigecycline (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Up to Week 12
Any untoward medical occurrence in a participant who received study treatment was considered an AE without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
次要结局
- Percentage of Participants With Clinical Response of Cure(Days 2-5, 7-14 and 21-28 during treatment and Days 1-3 after end of treatment)
- Number of Participants With Susceptible Microbiological Pathogens(Baseline and Week 12)
- Number of Participants With Eradication of Microbiological Pathogens(Week 12)