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



Status:Withdrawn
Conditions:Infectious Disease, Urology
Therapuetic Areas:Immunology / Infectious Diseases, Nephrology / Urology
Healthy:No
Age Range:18 - 85
Updated:10/28/2018
Start Date:October 19, 2018
End Date:October 28, 2019

Use our guide to learn which trials are right for you!

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

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 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
We found this trial at
4
sites
Seattle, Washington 98103
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Detroit, Michigan 48202
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Newark, New Jersey 07103
?
mi
from
Newark, NJ
Click here to add this to my saved trials
?
mi
from
Odense,
Click here to add this to my saved trials