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

Phase 2

Withdrawn

• Conditions: Complicated Urinary Tract Infections
• Interventions: Drug: Standard of care therapy; Drug: LYS228

• Registration Number: NCT03377426
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-14
• Study First Submitted QC: 2017-12-14
• Study First Posted: 2017-12-19
• Status Verified: 2018-10
• Study Start: 2018-10-19
• Last Update Submitted: 2018-10-24
• Last Update Posted: 2018-10-26
• Primary Completion: 2019-10-28
• Study Completion: 2019-10-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of care	Standard of care therapy	IV infusion of standard of care antibiotics for at least 5 days
LYS228	LYS228	IV infusion

Primary Outcome Measures

Name	Time	Method
Plasma Pharmacokinetics (PK) of LYS228: The systemic (or total body) clearance from plasma following intravenous administration (CL)	Day 5	Calculated based on LYS228 concentration in blood at different time points following drug administration on Day 5
Plasma Pharmacokinetics (PK) of LYS228: The observed maximum plasma concentration following drug administration (Cmax)	Day 5	Calculated based on LYS228 concentration in blood at different time points following drug administration on Day 5
Urine Pharmacokinetics (PK) of LYS228: Renal Clearance (CLr)	Day 5	Calculated based on LYS228 concentration in urine at different time points following drug administration on Day 5
Change from Baseline of the Clinical Response at Day 7	Baseline, Day 7	Clinical success at 7 days after randomization determined by signs and symptoms of infection and the need for additional antibiotics
Plasma Pharmacokinetics (PK) of LYS228: Area Under the Plasma Concentration-time Curve from time zero to the end of dosing interval tau (AUCtau)	Day 5	Calculated based on LYS228 concentration in blood at different time points following drug administration on Day 5
Plasma Pharmacokinetics (PK) of LYS228: The time to reach the maximum concentration after drug administration (Tmax)	Day 5	Calculated based on LYS228 concentration in blood at different time points following drug administration on Day 5
Plasma Pharmacokinetics (PK) of LYS228: The amount of time in which the unbound drug concentration exceeds the minimum inhibitory concentration of the organism (%fT>MIC)	Day 5	Calculated based on LYS228 concentration in blood at different time points following drug administration on Day 5
Urine Pharmacokinetics (PK) of LYS228: The amount of drug eliminated in Urine from 0 hours up to 6 hours following intravenus administration (Ae0-6h)	Day 5	Calculated based on LYS228 concentration in urine at different time points following drug administration on Day 5
Plasma Pharmacokinetics (PK) of LYS228: The volume of distribution at steady state following intravenous administration (Vss)	Day 5	Calculated based on LYS228 concentration in blood at different time points following drug administration on Day 5
Plasma Pharmacokinetics (PK) of LYS228: The terminal elimination half-life (T 1/2)	Day 5	Calculated based on LYS228 concentration in blood at different time points following drug administration on Day 5

Secondary Outcome Measures

Name	Time	Method
Change from Baseline of the Microbiological Response at Day 7	Baseline, Day 7	Microbiologic success at 7 days after randomization determined by microbial growth in urine culture

Trial Locations

Locations (1)

Novartis Investigative Site; 🇬🇷 Athens, Greece