A Study of Plazomicin Compared With Levofloxacin for the Treatment of Complicated Urinary Tract Infection (cUTI) and Acute Pyelonephritis (AP)

Achaogen

Status and phase: Completed; Phase 2

Conditions: Acute Pyelonephritis; Complicated Urinary Tract Infection

Treatments: Drug: levofloxacin; Drug: placebo; Drug: plazomicin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01096849

ACHN-490-002

Details and patient eligibility

About

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).

Enrollment: 145 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Documented or suspected cUTI/AP with clinical signs and symptoms
• Normal kidney function defined as creatinine clearance (CLcr) of ≥60mL/min using Cockcroft-Gault formula

Key Exclusion Criteria:

• Acute bacterial prostatis, orchitis, epididymitis, or chronic bacterial prostatis
• Gross heanaturia requiring intervention other than study drug
• Urinary tract surgery within 7 days of randomization or during the study period
• A known nonrenal source of infection diagnosed within 7 days of randomization
• A corrected QT interval > 440 msec
• History of hearing loss with onset before the age of 40 years, sensorineural hearing loss, or family history of hearing loss
• Pregnant or breastfeeding women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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145 participants in 3 patient groups

plazomicin (10 mg/kg)

Experimental group

Description:

Patients received two intravenous (IV) infusions daily for 5 consecutive days: 10 milligrams per kilogram (mg/kg) plazomicin followed by placebo.

Treatment:

Drug: placebo

Drug: plazomicin

plazomicin (15 mg/kg)

Experimental group

Description:

Patients received two IV infusions daily for 5 consecutive days: 15 mg/kg plazomicin followed by placebo.

Treatment:

Drug: placebo

Drug: plazomicin

levofloxacin

Active Comparator group

Description:

Patients received two IV infusions daily for 5 consecutive days: placebo followed by 750 milligrams (mg) levofloxacin.

Treatment:

Drug: levofloxacin

Drug: placebo