Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Tetraphase Pharmaceuticals, Inc
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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)
