A Study of Plazomicin Compared with Meropenem followed by Optional Oral Therapy for the Treatment of Complicated Urinary Tract Infection (cUTI), including Acute Pyelonephritis (AP)

• Register: EUCTR
• Last refreshed on: 10 October 2016
• Main ID: EUCTR2015-001588-37-EE
• Date of registration: 11/06/2015
• Prospective Registration: Yes
• Primary sponsor: Achaogen, Inc.
• Public title: A Study of Plazomicin Compared with Meropenem followed by Optional Oral Therapy for the Treatment of Complicated Urinary Tract Infection (cUTI), including Acute Pyelonephritis (AP)
• Scientific title: A Phase 3, Randomized, Multicenter, Double-Blind Study to Evaluate the Efficacy and Safety of Plazomicin Compared with Meropenem followed by Optional Oral Therapy for the Treatment of Complicated Urinary Tract Infection (cUTI), including Acute Pyelonephritis (AP), in Adults
• Date of first enrolment: 15/07/2015
• Target sample size: 530
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-001588-37
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

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

• Name: Clinical Trials Registration Group
• Affiliation: Achaogen, Inc.

• Name: Clinical Trials Registration Group
• Affiliation: Achaogen, Inc.

Key inclusion & exclusion 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:
- 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])


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

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

Intervention(s)

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
Other descriptive name: ACHN-490
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use

Pharmaceutical Form: Powder for solution for injection/infusion
INN or Proposed INN: meropenem trihydrate
CAS Number: 96036-03-2
Other descriptive name: MEROPENEM
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 1-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: Days 5 and 17 (+/- 2 days) after study drug start

Primary end point(s): Composite microbiological eradication and clinical cure rate in the microbiological modified intent-to-treat population

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

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 Outcome(s)

Timepoint(s) of evaluation of this end point: (1) Days 5 and 17 (+/- 2 days) after study drug start
(2) 32 Days

Secondary end point(s): (1) Composite microbiological eradication and clinical cure rate in the microbiologically evaluable population
(2) Overall incidence of adverse events

Secondary ID(s)

ACHN-490-009

Source(s) of Monetary Support

Achaogen, Inc.