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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
dburke1@tuftsmedicalcenter.org
|
| More Information |
https://www.clinicaltrials.gov/ct2/show/NCT03377426 |
The purpose of the study is to evaluate whether LYS228 can be developed for the treatment of complicated urinary tract infections
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
