NCT00379964已完成3 期
A Noncomparative, Multicenter, Open-Label, Study to Evaluate the Safety, Tolerability and Efficacy of MK0991 as Empirical Therapy in Indian Adults With Persistent Fever and Neutropenia
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Any clinical or laboratory serious drug-related adverse experience during the study drug therapy period plus 14 days posttherapy.
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability and efficacy of ertapenem sodium as initial therapy for the treatment of complicated urinary tract infections, including pyelonephritis in indian adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Patient has a low white cell count (less than 500/mm3) for at least 96 hours
- •Patient is indian and is greater than 18 years of age
- •Patient received chemotherapy for blood disorders and blood cancers
排除标准
- •Patient has an invasive fungal infection
- •Patient has a bacterial infection that is not controlled
- •Patient has allergy to the class of antifungals of study drug
- •Patient is not expected to survive at least 5 days
- •Patient is pregnant or breast-feeding
结局指标
主要结局
Any clinical or laboratory serious drug-related adverse experience during the study drug therapy period plus 14 days posttherapy.
时间窗: during the study drug therapy period plus 14 days posttherapy
次要结局
- Survival for at least 7 days following study therapy reduce fever during period of low white blood cell counts fungal infection no longer present following study therapy(7 days following study therapy)
研究者
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