A Post-marketing Surveillance (Pms) Study Of Safety And Effectiveness In Patients With Tigecycline Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 3,172
- 试验地点
- 33
- 主要终点
- Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics
研究概览
简要总结
The primary objective of this study is to identify any changes on the safety profile of adverse events and serious adverse events. And the secondary objective is to evaluate clinical response in the clinically evaluable population at test-of cure (TOC) or at the end of treatment (EOT) assessment, and microbiologic response at the subject level, if available.
详细描述
Prior to the conduct of this study, the investigator will explain the study objective, etc to prospective subjects on the basis of "explanatory material." The informed consent will be obtained in written form by each subject voluntarily.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study. Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study :
- •Adults 18 years of age or older, who have one of the followings:
- •Complicated skin and skin structure infections
- •Complicated intra-abdominal infections
- •Community-acquired bacterial pneumonia
排除标准
- •Subjects presenting with any of the following will not be included in the study:
- •Patients who have known hypersensitivity to tigecycline
- •Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption
研究组 & 干预措施
Patients who have approved indications of Tygacil
Approved indications of Tygacil
-complicated intraabdominal infection, complicated skin and skin structure infection, community-acquired bacterial pneumonia
干预措施: tigecycline (Drug)
结局指标
主要结局
Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics
时间窗: From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period.
Baseline and treatment characteristics included: prospectively/retrospectively collected data, geriatric status (\<65 years or \>=65 years), age categories, sex, duration of disease, infection site, severity of infection, general, present and past medical history, kidney disorder, liver disorder, total administration period of Tygacil, mean daily dose of Tygacil, past medication and therapy, and concomitant medications.
Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), and Unexpected AEs/ADRs
时间窗: From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period.
All AEs reported after start of administration of Tygacil were considered as on treatment and summarized. All AEs, except for those with causal relationship to the study drug assessed as "unlikely", were considered as ADRs. Unexpected AEs/ADRs were classified by medical review with reference to the approved local product document and confirmed by Pfizer.
次要结局
- Percentage of Participants With Clinical Response of Cure or Improvement at the TOC or EOT Assessment by Infection Site(At the TOC or EOT assessment)
- Percentage of Participants With Clinical Response of Cure or Improvement at the Test-of-Cure(TOC) or End-of-Treatment (EOT) Assessment(At the TOC or EOT assessment)
- Percentage of Participants by Microbiologic Response at the Participant Level (Prospective Study Phase)(At the TOC or EOT assessment)