LYS228 PK, Clinical Response, Safety and Tolerability in Patients With Complicated Urinary Tract Infection (cUTI)
Withdrawn before enrolling · Phase 2
Conditions studied: Complicated Urinary Tract Infections
In brief
The purpose of the study is to evaluate whether LYS228 can be developed for the treatment of complicated urinary tract infections
Key facts
- Study ID
- NCT03377426
- Run by
- Novartis Pharmaceuticals
- People needed
- 0
- Starts
- 2018-10-19
- Expected to finish
- 2019-10-28
- Last updated by the study team
- 2018-10-26
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.