Status:
WITHDRAWN
LYS228 PK, Clinical Response, Safety and Tolerability in Patients With Complicated Urinary Tract Infection (cUTI)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Complicated Urinary Tract Infections
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
The purpose of the study is to evaluate whether LYS228 can be developed for the treatment of complicated urinary tract infections
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 28 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03377426
Start Date
October 19 2018
End Date
October 28 2019
Last Update
October 26 2018
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Novartis Investigative Site
Detroit, Michigan, United States, 48202
2
Novartis Investigative Site
Newark, New Jersey, United States, 07102
3
Novartis Investigative Site
Seattle, Washington, United States, 98195
4
Novartis Investigative Site
Odense, Denmark, 5000