Conditions: Complicated Urinary Tract Infection Pyelonephritis
Keywords: cUTI
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 558
Healthy volunteers: no

Brief summary:
This is a Phase 3, multicenter, prospective, randomized, double-blind, double dummy study of CXA 201 IV infusions (1500 mg q8h) versus levofloxacin IV infusions (750 mg qd) for the treatment of adults with a cUTI (including pyelonephritis).

Detailed description:
Approximately 500 subjects will be enrolled into this study and randomized 1:1 to receive CXA-201 or comparator (levofloxacin) resulting in 250 subjects per treatment arm. Subject participation will require a minimum commitment of 35 days and a maximum of 42 days. Subjects will be hospitalized for the administration of all doses of IV study therapy. A test of cure visit will occur at 7 days after the last dose of study drug and a late follow-up evaluation or contact will occur a minimum of 28 days and a maximum of 35 days after the last dose of study drug.

Arms:
arm 1: CXA-201 IV infusion (1500mg q8) for 7 days arm 2: Levofloxacin IV infusion (750mg qd) for 7 days

Interventions: intervention 1: CXA-201 intervention 2: Levofloxacin
Intervention descriptions: intervention 1: CXA-201 IV infusion (1500mg q8) for 7 days intervention 2: Levofloxacin IV infusion (750mg qd) for 7 days

Protocol document: