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

• Status: Withdrawn
• Trial end date: 2019-10-28
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

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