LYS228 PK, Clinical Response, Safety and Tolerability in Patients With Complicated Urinary Tract Infection (cUTI)

Novartis Pharmaceuticals

Overview

The purpose of the study is to evaluate whether LYS228 can be developed for the treatment of complicated urinary tract infections

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Conditions

Complicated Urinary Tract Infections

Interventions

LYS228DRUG

LYS228 IV infusion

Standard of care therapyDRUG

IV infusion of standard of care antibiotics

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male and female patients 18 to 85 years of age with suspected and/or bacteriologically documented complicated UTI judges by the investigator to be serious (required patient to be hospitalized for treatment with intravenous antibiotics) Exclusion Criteria: * Urine Gram stain that demonstrated that a Gram-positive organism was present, or if urine culture results were available, demonstrated Gram- positive organisms were present at ≥10E5 CFU/mL * Urine culture result available at enrollment and demonstrating more than 2 different species of microorganisms regardless of the colony count * Urine culture result available demonstrating fungal UTI with colony count \>10E3 CFU/mL * Patient had received prior antibiotics within 72 hours before the initiation of study therapy * Patients with estimated glomerular filtration rate \< 30mL/min calculated based in study qualified formula

Locations (5)

Novartis Investigative Site

Detroit, Michigan, United States

Novartis Investigative Site

Newark, New Jersey, United States

Novartis Investigative Site

Seattle, Washington, United States

Novartis Investigative Site

Odense, Denmark

Outcomes

Primary Outcomes

Change from Baseline of the Clinical Response at Day 7

Clinical success at 7 days after randomization determined by signs and symptoms of infection and the need for additional antibiotics

Time frame: Baseline, Day 7

Plasma Pharmacokinetics (PK) of LYS228: Area Under the Plasma Concentration-time Curve from time zero to the end of dosing interval tau (AUCtau)