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

A Randomized, Controlled, Evaluator-blinded, Multi-center, Study to Evaluate LYS228 Pharmacokinetics, Clinical Response, Safety and Tolerability in Patients With Complicated Urinary Tract Infection

NCT03377426•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

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

Novartis Investigative Site

Athens, Greece

Key Dates

Start Date

October 19, 2018

Primary Completion Date

October 28, 2019

Completion Date

October 28, 2019

Last Updated

October 26, 2018

Conditions

Complicated Urinary Tract Infections

Interventions

LYS228

DRUG

Standard of care therapy

DRUG

Oral Sulopenem-etzadroxil/Probenecid Versus Ciprofloxacin for Uncomplicated Urinary Tract Infection in Adult Women

NCT03354598

Uncomplicated Urinary Tract Infections

View study

COMPLETEDPHASE3

Safety and Efficacy of Phenazopyridine Hydrochloride Tablets, USP 200 mg as an Analgesic for Short-Term Treatment in Female Subjects Suffering From Moderate-to-Severe Pain and Burning Upon Urination Associated With Uncomplicated Urinary Tract Infections (uUTI)

NCT01650051

Uncomplicated Urinary Tract Infections

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 26, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions