Clinical trial NCT01096849: A Study of Plazomicin Compared With Levofloxacin for the Treatment of Complicated Urinary Tract Infection (cUTI) and Acute Pyelonephritis (AP)
Official title: A Double-blind, Randomized, Comparator-controlled Study to Assess the Safety, Efficacy, and Pharmacokinetics of ACHN-490 Injection Administered IV in Patients With Complicated Urinary Tract Infections or Acute Pyelonephritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Complicated Urinary Tract Infection
Acute Pyelonephritis
Keywords: urinary tract infection
UTI
cUTI
pyelonephritis
AP
ACHN-490
Lead sponsor: Achaogen, Inc.
Sponsor class: INDUSTRY
First posted: 2010-03-31
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Percentage of Patients Who Attained Microbiological Eradication (MBE) at the Test of Cure (TOC) Visit in the Microbiological Intent to Treat (MITT) Population
timeFrame: Day 1 to TOC (Day 12)
measure: Percentage of Patients Who Attained MBE at the TOC Visit in the Microbiologically Evaluable (ME) Population
timeFrame: Day 1 to TOC (Day 12)
measure: Percentage of Patients With Treatment-Emergent Adverse Events (TEAE)
timeFrame: Day 1 to the end of study (Day 40)
Secondary outcomes:
measure: Percentage of Patients Who Attained Clinical Cure Based on Investigator and Sponsor Assessments at TOC Visit in the Intent-to-treat (ITT) Population
timeFrame: Day 1 to TOC (Day 12)
measure: Percentage of Patients Who Attained Clinical Cure Based on Investigator and Sponsor Assessments at the TOC Visit in the CE Population
timeFrame: Day 1 to TOC (Day 12)
measure: Percentage of Patients Who Attained Clinical Cure Based on Investigator and Sponsor Assessments at the End of Treatment (EOT) Visit in the CE Population
timeFrame: Day 1 to EOT (Day 5)
measure: Percentage of Patients Who Attained MBE at the EOT Visit in the ME Population
timeFrame: Day 1 to EOT (Day 5)
measure: Percentage of Patients Who Attained MBE at the EOT Visit in the MITT Population
timeFrame: Day 1 to EOT (Day 5)
measure: Percentage of Patients Who Attained MBE at the TOC Visit in the ME Population by Baseline Pathogen
timeFrame: Day 1 to TOC (Day 12)
measure: Percentage of Patients Who Attained MBE at the TOC Visit in the ME Population Stratified by Infection Category
timeFrame: Day 1 to TOC (Day 12)
measure: Percentage of Patients Who Attained MBE at the TOC Visit in the ME Population by Country/Region
timeFrame: Day 1 to TOC (Day 12)
measure: Time (Days) to Resolution of Signs and Symptoms of cUTI and AP in the MITT Population
timeFrame: Day 1 to End of Study (Day 40)
measure: Time (Days) to Clinical Cure Based on Investigator's and Sponsor's Assessments in the MITT Population
timeFrame: Day 1 to End of Study (Day 40)
measure: Time (Days) to Defervescense in the MITT Population
timeFrame: Day 1 to End of Study (Day 40)
measure: Percentage of Patients Experiencing a Clinical Relapse or Microbiological Recurrence in the ME Population
timeFrame: Day 1 to LTFU (Day 40)
measure: Percentage of Patients With a Superinfection or New Infection in the ME Population
timeFrame: Day 1 to to End of Study (Day 40)
Other outcomes:
Locations:
Study officials:
affiliation: Achaogen, Inc.
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Connolly LE, Riddle V, Cebrik D, Armstrong ES, Miller LG. A Multicenter, Randomized, Double-Blind, Phase 2 Study of the Efficacy and Safety of Plazomicin Compared with Levofloxacin in the Treatment of Complicated Urinary Tract Infection and Acute Pyelonephritis. Antimicrob Agents Chemother. 2018 Mar 27;62(4):e01989-17. doi: 10.1128/AAC.01989-17. Print 2018 Apr.