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

Achaogen, Inc.0 个研究点目标入组 530 人开始时间: 2015年8月13日最近更新: 2017年10月30日

试验速览

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•- 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 or 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

•- 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, autoimmune disease of the inner ear, or family history of hearing loss (excluding age-related hearing loss [onset after age 65 years])

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