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

• Status: Completed
• Trial end date: 2016-09-22
• Target enrollment: 0
• Participant gender: All

Summary

This was a randomized, multicenter, multinational, double-blind study comparing the efficacy and safety of plazomicin compared with meropenem followed by optional oral (PO) therapy in the treatment of cUTI, including AP, in adults.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Achaogen, Inc.
• Treatments: Levofloxacin; Meropenem; Ofloxacin; Thienamycins

Criteria

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 participants 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])