Efficacy and Safety Study of Eravacycline Compared With Ertapenem in Participants With Complicated Urinary Tract Infections

Inclusion Criteria

• Male or female participant with either:
• Pyelonephritis and normal urinary tract anatomy (approximately 50% of the total population), or
• cUTI with at least one of the following conditions associated with a risk for developing cUTI:
• Indwelling urinary catheter
• Urinary retention (at least approximately 100 milliliters (mL) of residual urine after voiding)
• History of neurogenic bladder
• Partial obstructive uropathy (for example, nephrolithiasis, bladder stones, and ureteral strictures)
• Azotemia of renal origin (not congestive heart failure [CHF] or volume related) such that the serum blood urea nitrogen [BUN] is elevated (>20 milligrams [mg]/deciliters [dL]) and the serum BUN:creatinine ratio is 10 days of antibiotic treatment to cure the acute cUTI or likely to receive ongoing antibacterial drug prophylaxis prior to the Follow Up visit (21-28 days after randomization) [for example, participants with chronic vesiculo-ureteral reflux]
• Unlikely to survive at least through the duration of the study
• Hypotension, systolic blood pressure ≤90 millimeters of mercury [mmHg]
• Complicated pyelonephritis with complete obstruction or known or suspected renal or perinephric abscess, emphysematous pyelonephritis, or Any condition likely to require surgery to achieve cure (this does not include procedure to place catheters or obtain diagnosis)
• Known or suspected urinary fungal infection
• Uncomplicated lower urinary tract infections
• Suspected or confirmed active prostatitis, or currently under treatment for prostatitis
• High risk for cUTI due to Pseudomonas (for example, history of prior cUTIs due to Pseudomonas, ≥20 mg once a day prednisone or equivalent steroid, and other risk factors as perceived by the Investigator)
• History of renal transplantation
• Presence of an ileal loop
• Any history of trauma to the pelvis or urinary tract occurring within 30 days of screening
• Indwelling urinary catheters present at screening which are not expected to be removed or replaced within 72 hours of enrollment (for example, nephrostomy tubes, stents, urethral and suprapubic catheters).
• Known concomitant human immunodeficiency virus (HIV) infection with CD4 counts below 200 within the last six months, or an acquired immune deficiency syndrome (AIDS) defining diagnosis within the last six months
• Neutropenia (Absolute neutrophil count <1, 000 polymorphonuclear leukocytes [PMNs]/microliters [µL])
• Participation in a study with an experimental drug or device within 30 days prior to enrollment
• Known or suspected hypersensitivity to tetracyclines, carbapenems, or β-lactams
• History of seizures
• Any other unstable or clinically significant concurrent medical condition (for example, immunosuppressive therapy, chemotherapy, class IV heart or lung disease, end stage renal disease, or requiring hemodialysis) that would, in the opinion of the Investigator, jeopardize the safety of a participant and/or their compliance with the protocol