A Study of Plazomicin Compared With Meropenem for the Treatment of Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis (AP)

Key Inclusion Criteria:

- Pyuria

- 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

Key Exclusion Criteria:

- 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 (excluding age-related hearing loss [onset
after age of 65 years])