NCT00389987已完成3 期
A Prospective, Multicenter, Double-Blind With In-House Blinding, Randomized, Comparative Study to Evaluate the Efficacy, Safety, and Tolerability of Ertapenem Sodium Versus Piperacillin/Tazobactam in the Treatment of Complicated Intra-Abdominal Infections in Hospitalized Adults
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 300
- 主要终点
- In microbiologically evaluable patients, ertapenem will be at least as effective as piperacillin/tazobactam at the 2-weeks post-treatment Early Follow-up Assessment.
研究概览
简要总结
This study is designed to compare the efficacy of ertapenem and piperacillin/tazobactam with respect to the clinical response in baseline microbiologically evaluable patients; and to evaluate the tolerability and safety of ertapenem compared to piperacillin/tazobactam.
详细描述
Original label approved November 2001
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
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
- •Male or female patients (greater or equal to 18 years of age)
- •Intraoperative/Postoperative Enrollment: Upon visual confirmation of an intra-abdominal infection.
- •Preoperative Enrollment: Patients may be enrolled preoperatively if they meet certain criteria
排除标准
- •Failure to meet all inclusion criteria.
- •Patients who are considered unlikely to survive the 6-8 week study period.
- •Pregnant or nursing women, or fertile women not practicing adequate methods of contraception.
结局指标
主要结局
In microbiologically evaluable patients, ertapenem will be at least as effective as piperacillin/tazobactam at the 2-weeks post-treatment Early Follow-up Assessment.
时间窗: 2-weeks post-treatment
次要结局
- In microbiologically evaluable patients, ertapenem will be at least as effective as piperacillin/tazobactam at the 4-6 weeks post-treatment Late Follow-up Assessment.(4-6 Weeks post-treatment)
研究者
相似试验
已完成
3 期
Ertapenem Sodium (MK-0826) Versus Piperacillin/Tazobactam Sodium for the Treatment of Diabetic Foot Infections in Chinese Adults (MK-0826-061)Diabetic Foot InfectionNCT01370616Merck Sharp & Dohme LLC565
已完成
4 期
T.E.A. Study Three Days Ertapenem Versus Three Days Ampicillin- SulbactamIntra-Abdominal InfectionNCT00630513University of Bologna142
已完成
3 期
Comparative Study of Ertapenem Versus Another Antibiotic in the Treatment of Diabetic Foot Infections in Adults (0826-034)Foot Infections in Diabetic PatientsNCT00229112Merck Sharp & Dohme LLC400
已完成
3 期
Efficacy and Safety of Ertapenem Sodium (MK-0826) Following Colorectal Surgery in Chinese Adults (MK-0826-056)InfectionSurgical Site InfectionNCT01254344Merck Sharp & Dohme LLC599
已完成
3 期
To Evaluate Ezetimibe Plus Atorvastatin Versus Atorvastatin in Patients With High Cholesterol Not Controlled on Atorvastatin 20 mg (0653-079)(COMPLETED)HypercholesterolemiaNCT00276458Organon and Co196