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

Novartis

Status and phase: Withdrawn; Phase 2

Conditions: Complicated Urinary Tract Infections

Treatments: Drug: Standard of care therapy; Drug: LYS228

Study type: Interventional

Funder types: Industry

Identifiers

NCT03377426

CLYS228X2201

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

LYS228

Experimental group

Description:

IV infusion

Treatment:

Drug: LYS228

Standard of care

Active Comparator group

Description:

IV infusion of standard of care antibiotics for at least 5 days

Treatment:

Drug: Standard of care therapy