Conditions: Complicated Urinary Tract Infection Acute Pyelonephritis
Keywords: cUTI AP ACHN-490 anti-infective anti-bacterial antibiotic anti-microbial UTI bacterial infection Gram-negative
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 609
Healthy volunteers: no

Brief summary:
This was a randomized, multicenter, multinational, double-blind study comparing the efficacy and safety of plazomicin compared with meropenem followed by optional oral (PO) therapy in the treatment of cUTI, including AP, in adults.

Detailed description:

Arms:
arm 1: Patients received 15 milligrams per kilogram (mg/kg) plazomicin as an intravenous (IV) infusion once daily followed by matching placebo infusions 8 and 16 hours later. After a minimum of 4 days of IV plazomicin, patients could switch to 250 or 500 mg oral levofloxacin for a total duration of 7 to 10 days (IV plus oral). arm 2: Patients received 1.0 g meropenem as an IV infusion every 8 hours (q8h). After a minimum of 4 days of IV meropenem, patients could switch to 250 or 500 mg oral levofloxacin for a total duration of 7 to 10 days (IV plus oral).

Interventions: intervention 1: plazomicin intervention 2: meropenem intervention 3: levofloxacin (oral)
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol document: