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LYS228 Pharmacokinetics for Complicated UTI


Title A Randomized, Controlled, Evaluator-blinded, Multi-center, study to evaluate LYS228 pharmacokinetics, clinical response, safety and tolerability in patients with complicated urinary tract infection 
Therapeutic Area Urinary Tract Infections
Principal Investigator Dr. Yoav Golan
Min Age 18 Years
Max Age 85 Years
Gender All
Contact Deirdre Burke
617-636-3665
More Information https://www.clinicaltrials.gov/ct2/show/NCT03377426

Overview

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

Study Details

Inclusion Criteria

  • Male and female patients 18 to 85 years of age
  • 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

  • Prior antibiotics within the past 72 hours
  • Urine culture resulting with fungal UTI colony count of more than 130 CFU/mL
  • Urine culture resulting in more than 2 different species of microorganisms, or if a gram positive organism is present with >= 105 CFU/mL count. 

Study Requirements

Blood draw, Urine samples, clinic visits