Conditions: Complicated Urinary Tract Infection Acute Pyelonephritis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 80
Healthy volunteers: no

Brief summary:
This study is a double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of IV ETX2514SUL in patients with complicated urinary tract infections (cUTIs) who are otherwise relatively healthy.

Detailed description:
This study is a double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of IV ETX2514SUL in patients with cUTIs who are otherwise relatively healthy. Patients with Acute Pyelonephritis may also be enrolled. Approximately 80 patients will be randomized to receive either 1 g ETX2514/1 g sulbactam IV or matching placebo every 6 hours (q6h). All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h.

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Sulbactam-ETX2514 intervention 2: Placebo intervention 3: Imipenem-cilastatin
Intervention descriptions: intervention 1: The ETX2514SUL regimen of 1 g ETX2514/1 g sulbactam infused over 3 hours q6h. intervention 2: Matching 1g IV solution. intervention 3: All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h.

Protocol document:
Prot_000.pdf: 



















































































































































SAP_001.pdf: