Complicated Urinary Tract Infection (cUTI) Acute Pyelonephritis (AP) MedDRA version: 19.0 Level: PT Classification code 10054088 Term: Urinary tract infection bacterial System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: plazomicin
Product Code: ACHN-490
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: To be determined
CAS Number: 1380078-95-4
Current Sponsor code: ACHN-490
Sponsors
Achaogen, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Pyuria - Have a pretreatment baseline urine culture obtained within 36 hours before the start of administration of the first dose of study drug - Clinical signs and/or symptoms of acute pyelonephritis or complicated urinary tract infection - Normal renal function or moderate renal impairment (calculated creatinine clearance (CLcr) at screening > 30 mL/min as estimated by the Cockcroft-Gault formula). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 371 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 159
Exclusion criteria
Exclusion criteria: - Confirmed fungal urinary tract infection at the time of randomization - Known urinary tract infection or colonization with Gram-positive pathogens - Current cUTI or AP is known to be caused by a pathogen resistant to meropenem - Female patients of childbearing potential if they are known to be pregnant or have a positive pregnancy test at screening, breastfeeding, or unable or unwilling to use a highly effective method of birth control during the study and for at least 30 days following the last dose of study medication - Any rapidly progressing disease or immediately life-threatening illness - Documented presence of immunodeficiency or an immunocompromised condition - Documented or known history of otologic surgery or disease including use of hearing aid, head injury leading to otologic damage, Ménière's disease, tumor of the head, neck, or auditory system, perilymphatic fistula, or autoimmune disease of the inner ear, or family history of hearing loss (excluding age-related hearing loss [onset after age of 65 years])
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to demonstrate the non-inferiority of plazomicin compared with meropenem based on the difference in composite microbiological eradication and clinical cure rate at both the Day 5 and test-of-cure (TOC) visits;Secondary Objective: The secondary objectives of this study are to: - Summarize the composite microbiological eradication and clinical cure rates of plazomicin compared with meropenem at the Day 5 and TOC visits - Evaluate the safety of plazomicin in patients with cUTI including AP ;Primary end point(s): Composite microbiological eradication and clinical cure rate in the microbiological modified intent-to-treat population;Timepoint(s) of evaluation of this end point: Days 5 and 17 (+/- 2 days) after study drug start | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): (1) Composite microbiological eradication and clinical cure rate in the microbiologically evaluable population (2) Overall incidence of adverse events;Timepoint(s) of evaluation of this end point: (1) Days 5 and 17 (+/- 2 days) after study drug start (2) 32 Days | — |
Countries
Argentina, Brazil, Bulgaria, Chile, Colombia, Czech Republic, Estonia, Georgia, Germany, Hungary, Latvia, Mexico, Poland, Romania, Russian Federation, Serbia, Spain, Ukraine, United Kingdom, United States
Contacts
Public ContactClinical Trials Registration Group
Achaogen, Inc.
Outcome results
None listed