Efficacy and Safety Study of Eravacycline Compared With Levofloxacin in Complicated Urinary Tract Infections
Efficacy and Safety Study of Eravacycline Compared With Levofloxacin in Complicated Urinary Tract Infections
This is a phase 3, randomized, double-blind, double-dummy, multicenter, prospective study to
 assess the efficacy and safety of eravacycline compared with levofloxacin in participants
 with complicated urinary tract infections (cUTI).
This study began with a 3-arm Lead-in portion to determine the oral (PO) dosing (200 or 250
 milligrams [mg]) of eravacycline to be used with intravenously (IV) administered eravacycline
 for the Pivotal portion (2 arms). A PO dose of 200 mg was selected based on the unblinded
 Lead-in analysis.
Inclusion Criteria:

 1. Male and female participants with either:

 a. Pyelonephritis and normal urinary tract anatomy (approximately 50% of the total
 population), OR b. cUTI with at least 1 of the following conditions associated with a risk
 for developing cUTI: i. Indwelling urinary catheter ii. Urinary retention (approximately
 100 milliliters of residual urine after voiding) iii. Neurogenic bladder iv. Partial
 obstructive uropathy (such as, nephrolithiasis, bladder stones, and ureteral strictures) v.
 Azotemia of renal origin (not congestive heart failure or volume related) such that the
 serum blood urea nitrogen (BUN) is elevated (>20 mg/deciliters) AND the serum BUN:
 creatinine ratio is <15 vi. Surgically modified or abnormal urinary tract anatomy (such as,
 bladder diverticula, redundant urine collection system) EXCEPT surgery within the last
 month

 Exclusion Criteria:

 1. Concurrent use of non-study antibacterial drug therapy that would have a potential
 effect on outcome evaluations in participants with cUTI, including:

 1. Participants with a history of a levofloxacin-resistant urinary tract infection

 2. Likely to receive ongoing antibacterial drug prophylaxis prior to the late
 Post-Treatment visit (such as, participants with vesiculo-ureteral reflux)