Phase 2 N=145 Randomized Double-blind Treatment

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

Complicated Urinary Tract Infection · Acute Pyelonephritis

Bottom Line

View on ClinicalTrials.gov: NCT01096849 ↗

Enrolled (actual)

145

Serious AEs

2.1%

Results posted

Aug 2018

Primary outcome: Primary: Percentage of Patients Who Attained Microbiological Eradication (MBE) at the Test of Cure (TOC) Visit in the Microbiological Intent to Treat (MITT) Population — 50; 60.8; 58.6 percentage of patients

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: levofloxacin (Drug); plazomicin (Drug); placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Achaogen, Inc.
Primary completion: Apr 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Patients Who Attained Microbiological Eradication (MBE) at the Test of Cure (TOC) Visit in the Microbiological Intent to Treat (MITT) Population	50; 60.8; 58.6	—
PRIMARY Percentage of Patients Who Attained MBE at the TOC Visit in the Microbiologically Evaluable (ME) Population	85.7; 88.6; 81.0	—
PRIMARY Percentage of Patients With Treatment-Emergent Adverse Events (TEAE)	31.8; 35.1; 47.7	—
SECONDARY Percentage of Patients Who Attained Clinical Cure Based on Investigator and Sponsor Assessments at TOC Visit in the Intent-to-treat (ITT) Population	63.6; 69.7; 70.2; 59.1; 69.7; 68.1	—
SECONDARY Percentage of Patients Who Attained Clinical Cure Based on Investigator and Sponsor Assessments at the TOC Visit in the CE Population	66.7; 76.6; 78.6; 66.7; 76.6; 76.2	—
SECONDARY Percentage of Patients Who Attained Clinical Cure Based on Investigator and Sponsor Assessments at the End of Treatment (EOT) Visit in the CE Population	94.4; 82.8; 88.1; 94.4; 82.8; 85.7	—
SECONDARY Percentage of Patients Who Attained MBE at the EOT Visit in the ME Population	85.7; 82.9; 76.2	—
SECONDARY Percentage of Patients Who Attained MBE at the EOT Visit in the MITT Population	83.3; 74.5; 72.4	—
SECONDARY Percentage of Patients Who Attained MBE at the TOC Visit in the ME Population by Baseline Pathogen	100; 100; 100; 83.3; 87.5; 80.0	—
SECONDARY Percentage of Patients Who Attained MBE at the TOC Visit in the ME Population Stratified by Infection Category	100; 88.9; 80; 80.0; 88.2; 83.3	—
SECONDARY Percentage of Patients Who Attained MBE at the TOC Visit in the ME Population by Country/Region	66.7; 66.7; 0; 100; 100; 100	—
SECONDARY Time (Days) to Resolution of Signs and Symptoms of cUTI and AP in the MITT Population	11.8; 10.7; 13.3	—
SECONDARY Time (Days) to Clinical Cure Based on Investigator's and Sponsor's Assessments in the MITT Population	9.5; 7.0; 7.6; 9.5; 7.0; 7.4	—
SECONDARY Time (Days) to Defervescense in the MITT Population	1.0; 2.1; 2.0	—
SECONDARY Percentage of Patients Experiencing a Clinical Relapse or Microbiological Recurrence in the ME Population	0; 14.3; 6.3; 0; 6.5; 23.5	—
SECONDARY Percentage of Patients With a Superinfection or New Infection in the ME Population	28.6; 8.6; 0; 0; 2.9; 4.8	—

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).

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01096849). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.