An Open-label, Randomized Equivalence Trial and Cost-effectiveness Analysis of Ertapenem Versus Other Carbapenems for Treatment of Extended -Spectrum Beta-Lactamase (ESBL)-Producing Gram-negative Bacterial Infections
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of subjects with cure or improvement
研究概览
简要总结
Adult patients with ESBL-producing Gram negative infections are randomized to receive ertapenem or meropenem/imipenem. Clinical and microbiological responses between both groups are compared.
详细描述
Ertapenem is active against ESBL-producing Gram negative bacteria. This study is conducted to determine if ertapenem is effective against ESBL-producing Gram negative infections similar to meropenem/imipenem.
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
- None
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
- •Hospitalized patients aged >18 years with documented ESBL +ve GNB infection
- •Receive meropenem or imipenem/cilastatin as empiric antibiotic therapy
排除标准
- •Having been treated with meropenem or imipenem/cilastatin for longer than 72 hours
- •Have active P. aeruginosa co-infection
- •Pregnancy or breast feeding
- •Allergy to carbapenems
研究组 & 干预措施
Ertapenem
Ertapenem 1 gram per day for 7 to 14 days
干预措施: Ertapenem (Drug)
Meropenem or Imipenem
Meropenem or Imipenem o.5 or 1 gram 3 to 4 times a day for 7 to 14 days
干预措施: Meropenem or Imipenem (Drug)
结局指标
主要结局
Number of subjects with cure or improvement
时间窗: 14 days
Cure Improvement Persistence Death from Infection
次要结局
- Number of subjects with eradication of the causative bacteria(14 days)
研究者
Visanu Thamlikitkul
Division of Infectious Diseases and tropical medicine, Department of medicine, Faculty of Medicine Siriraj Hospital.
Mahidol University