EUCTR2015-001588-37-CZ进行中（未招募）1 期
A Phase 3, Randomized, Multicenter, Double-Blind Study to Evaluate the Efficacy and Safety of Plazomicin Compared with Meropenem followed by Optional Oral Therapy for the Treatment of Complicated Urinary Tract Infection (cUTI), including Acute Pyelonephritis (AP), in Adults
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 530
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
- •- Have a pretreatment baseline urine culture obtained within 36 hours before the start of administration of the first dose of study drug
- •- Clinical signs and/or symptoms of acute pyelonephritis or complicated urinary tract infection
- •- Normal renal function to moderate renal impairment
- •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 371
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 159
排除标准
- •- Confirmed fungal urinary tract infection at the time of randomization
- •- Known urinary tract infection or colonization with Gram-positive pathogens
- •- Current cUTI or AP is known to be caused by a pathogen resistant to meropenem
- •- Female patients of childbearing potential if they are known to be pregnant or have a positive pregnancy test at screening, breastfeeding, or unable or unwilling to use a highly effective method of birth control during the study and for at least 30 days following the last dose of study medication
- •- Any rapidly progressing disease or immediately life-threatening illness
- •- Documented presence of immunodeficiency or an immunocompromised condition
- •- Documented or known history of otologic surgery or disease including use of hearing aid, head injury leading to otologic damage, Ménière's disease, tumor of the head, neck, or auditory system, perilymphatic fistula, or autoimmune disease of the inner ear, or family history of hearing loss
研究者
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