Conditions: cUTI
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 908
Healthy volunteers: no

Brief summary:
This is a phase 3, randomized, double-blind, double-dummy, multicenter, prospective study to assess the efficacy and safety of eravacycline compared with levofloxacin in participants with complicated urinary tract infections (cUTI).

Detailed description:
This study began with a 3-arm Lead-in portion to determine the oral (PO) dosing (200 or 250 milligrams \[mg\]) of eravacycline to be used with intravenously (IV) administered eravacycline for the Pivotal portion (2 arms). A PO dose of 200 mg was selected based on the unblinded Lead-in analysis.

Arms:
arm 1: Eravacycline was administered IV at a dose of 1.5 mg per kilogram (kg) of body weight every 24 hours (q24h). At minimum, the first 3 doses were administered IV. After an IV-to-PO transition, provided adequate clinical improvement, participants were administered 200 mg PO twice a day for a total therapy of 7 dosing cycles. arm 2: Levofloxacin (750 mg) was administered IV q24h. At minimum, the first 3 doses were administered IV. After an IV-to-PO transition, provided adequate clinical improvement, participants were administered 750 mg PO once a day for a total therapy of 7 dosing cycles.

Interventions: intervention 1: Eravacycline intervention 2: Levofloxacin
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: