EUCTR2012-000726-21-BG进行中（未招募）不适用
An Open-Label, Randomized, Multicenter, Phase III Study of Ceftazidime Avibactam (CAZ-AVI) and Best Available Therapy for the Treatment of Infections Due to Ceftazidime Resistant Gram Negative Pathogens
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Patient must be =18 and =90 years of age
- •2.Female patients can participate if they are surgically sterile or
- •completed menopause or females capable of having children and agree not to attempt pregnancy while receiving IV study therapy and for a
- •period of 7 days after
- •3.Patient has a ceftazidime-resistant Gram negative pathogen that was
- •isolated from an appropriate culture within 5 days prior to study entry
- •(ie, within 5 days prior to Screening; the study-qualifying culture), which
- •was determined to be the causative agent of the entry infection
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 256
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 144
排除标准
- •1.Patient has an APACHE II score >30 (cIAI patients only)
- •2.Patient has an infection due to Gram negative pathogen that is unlikely
- •to respond to CAZ-AVI treatment (eg, Acinetobacter spp.,
- •Stenotrophomonas spp.)
- •3.Patient is receiving hemodialysis or peritoneal dialysis or had a renal
- •transplant Patient is immunocompromised
- •4.Patient has a rapidly progressive or terminal illness with a high risk of
- •mortality due to any cause, including acute hepatic failure, respiratory
- •failure or severe septic shock such that they are unlikely to survive the
- •4- to 5-week study period.
研究者
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