Conditions: Complicated Urinary Tract Infection Acute Pyelonephritis
Keywords: urinary tract infection UTI cUTI pyelonephritis AP ACHN-490
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 145
Healthy volunteers: no

Brief summary:
This was a multi-center, multi-national, double-blind, randomized, comparator-controlled study of plazomicin administered intravenously compared with levofloxacin, a standard approved intravenous therapy for complicated urinary tract infection (cUTI) and acute pyelonephritis (AP).

Detailed description:

Arms:
arm 1: Patients received two intravenous (IV) infusions daily for 5 consecutive days: 10 milligrams per kilogram (mg/kg) plazomicin followed by placebo. arm 2: Patients received two IV infusions daily for 5 consecutive days: 15 mg/kg plazomicin followed by placebo. arm 3: Patients received two IV infusions daily for 5 consecutive days: placebo followed by 750 milligrams (mg) levofloxacin.

Interventions: intervention 1: levofloxacin intervention 2: plazomicin intervention 3: placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol document: