NCT03377426

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

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Complicated Urinary Tract Infections

Interventions

Type	Name	Description
DRUG	LYS228	LYS228 IV infusion
DRUG	Standard of care therapy	IV infusion of standard of care antibiotics

Timeline

• Start date: 2018-10-19
• Primary completion: 2019-10-28
• Completion: 2019-10-28
• First posted: 2017-12-19
• Last updated: 2018-10-26

Locations

5 sites across 3 countries: United States, Denmark, Greece

Regulatory

• FDA-regulated drug study