Complicated Urinary Tract Infections MedDRA version: 19.0 Level: PT Classification code 10046571 Term: Urinary tract infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: eravacycline
Product Code: TP-434
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: ERAVACYCLINE
CAS Number: 1207283-85-9
Current Sponsor code: TP-434
Other desc
Sponsors
Tetraphase Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female subjects with either: a. Pyelonephritis and normal urinary tract anatomy (approximately 50% of the total population), OR b. cUTI with at least one of the following conditions associated with a risk for developing cUTI: i. Indwelling urinary catheter ii. Urinary retention (at least approximately 100 mL of residual urine after voiding) iii. History of neurogenic bladder iv. Partial obstructive uropathy (e.g., nephrolithiasis, bladder stones, and ureteral strictures) v. Azotemia of renal origin (not congestive heart failure [CHF] or volume related) such that the serum blood urea nitrogen [BUN] is elevated (> 20 mg/dL) AND the serum BUN:creatinine ratio is 100.4°F / 38°C) or hypothermia (oral, rectal, tympanic, or by temporal artery temperature =65 years) yes F.1.3.1 Number of subjects for this age range 420
Exclusion criteria
Exclusion criteria: 1. Use of systemic antibiotics effective in cUTI within 72 hours prior torandomization EXCEPT under the following circumstances: a. Subjects with suspected acute cUTI who have received a single dose of effective non-study antibiotics for the acute cUTI b. Signs and symptoms of cUTI developed while on the antibiotic for another indication 2. History of an ertapenem-resistant urinary tract infection within 1 year of consent 3. Likely to require > 10 days of antibiotic treatment to cure the acute cUTI or likely to receive ongoing antibacterial drug prophylaxis prior to the FU visit (eg. Subjects with chronic vesiculo-ureteral reflux). 4. Unlikely to survive at least through the duration of the study 5. Hypotension, systolic blood pressure = 90 mmHg 6. 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) 7. Known or suspected urinary fungal infection 8. Uncomplicated lower urinary tract infections 9. Suspected or confirmed active prostatitis, or currently under treatment for prostatitis 10. High risk for cUTI due to Pseudomonas sp. (eg, history of prior cUTIs due to Pseudomonas, = 20 mg QD prednisone or equivalent steroid, and other risk factors as perceived by the Investigator) 11. History of renal transplantation 12. Presence of an ileal loop 13. Any history of trauma to the pelvis or urinary tract occurring within 30 days prior to consent 14. Indwelling urinary catheters present at screening which are not expected to be removed or replaced within 72 hours of randomization (eg, nephrostomy tubes, stents, urethral and suprapubic catheters). 15. Known concomitant HIV infection with CD4 counts below 200 cells/µL within six months prior to consent, or an AIDS defining diagnosis within six months prior to consent 16. Neutropenia (ANC < 1,000 PMNs/µL) 17. Participation in a study with an experimental drug or device within 30 days prior to consent 18. Known or suspected hypersensitivity to tetracyclines, carbapenems, or ß-lactams 19. History of seizures 20. Any other unstable or clinically significant concurrent medical condition (e.g., 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 subject and/or their compliance with the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary endpoint will be the microbiologic outcome at the TOC visit in the micro-MITT and ME populations. For the FDA: the primary endpoints of the study are the responder rates (clinical cure and microbiologic success) at the End of IV (EOI) and Test of Cure (TOC) visits in the micro-ITT population. ;Main Objective: The primary objective is to demonstrate that eravacycline is non-inferior to ertapenem in microbiological outcome in the microbiological modified intent-to-treat (micro-MITT) and microbiologically evaluable (ME) populations at the Test of Cure (TOC) visit. For the FDA: The primary objective is to demonstrate that IV eravacycline is non-inferior to ertapenem in responder outcome (clinical cure and microbiologic success) in the microbiological intent-to-treat (micro-ITT) population at the End of IV (EOI) visit (within 1 day of the completion of IV study drug treatment) and Test of Cure (TOC) visit (defined as 14-17 days after randomization). ;Secondary Objective: The secondary objectives of the study are: 1. To compare responder outcomes in the treatment arms at Day 5. 2. To compare clinical outcomes in the treatment arms at Day 5, EOI, End of Treatment (EOT), TOC, and Follow-up (FU) visits. 3. To compare microbiologic outcomes in the treatment arms at Day 5, EOI, EOT, TOC and FU visits. 4. To assess safety and tolerability of IV eravacycline administration. 5. To explore pharmacokinetic (PK) parameters of IV eravacycline.;Timepoint(s) of evaluation of this end point: End of IV (EOI) and Test of Cure (TOC) visits | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Day 5, End of IV (EOI), EOT (End of Treatment), Test of Cure (TOC), and Follow-Up (FU);Secondary end point(s): The secondary endpoints of the study are - Responder rate at Day 5 - Clinical outcome at Day 5, End of IV (EOI), EOT (End of Treatment), Test of Cure (TOC), and Follow-Up (FU) - Microbiologic outcome at Day 5, EOI, EOT, TOC, and FU | — |
Countries
Austria, Belarus, Bulgaria, Czech Republic, Estonia, Georgia, Hungary, India, Latvia, Moldova, Republic of, Poland, Romania, Russian Federation, Slovakia, Spain, Ukraine, United States
Contacts
Public ContactProject Manager
PSI Co Ltd.
Outcome results
None listed