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

Complicated Urinary Tract Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03377426
• Other study ID #: CLYS228X2201
• Status: Withdrawn
• Phase: Phase 2
• Start date: October 19, 2018
• Est. completion date: October 28, 2019

Study information

• Verified date: October 2018
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 28, 2019
• Est. primary completion date: October 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Complicated Urinary Tract Infections
• Infection
• Urinary Tract Infections

Intervention

Drug:
• LYS228
LYS228 IV infusion
• Standard of care therapy
IV infusion of standard of care antibiotics

Locations

Country	Name	City	State
Denmark	Novartis Investigative Site	Odense
Greece	Novartis Investigative Site	Athens
United States	Novartis Investigative Site	Detroit	Michigan
United States	Novartis Investigative Site	Newark	New Jersey
United States	Novartis Investigative Site	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Denmark,  Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline of the Clinical Response at Day 7	Clinical success at 7 days after randomization determined by signs and symptoms of infection and the need for additional antibiotics	Baseline, Day 7
Primary	Plasma Pharmacokinetics (PK) of LYS228: Area Under the Plasma Concentration-time Curve from time zero to the end of dosing interval tau (AUCtau)	Calculated based on LYS228 concentration in blood at different time points following drug administration on Day 5	Day 5
Primary	Plasma Pharmacokinetics (PK) of LYS228: The observed maximum plasma concentration following drug administration (Cmax)	Calculated based on LYS228 concentration in blood at different time points following drug administration on Day 5	Day 5
Primary	Plasma Pharmacokinetics (PK) of LYS228: The time to reach the maximum concentration after drug administration (Tmax)	Calculated based on LYS228 concentration in blood at different time points following drug administration on Day 5	Day 5
Primary	Plasma Pharmacokinetics (PK) of LYS228: The systemic (or total body) clearance from plasma following intravenous administration (CL)	Calculated based on LYS228 concentration in blood at different time points following drug administration on Day 5	Day 5
Primary	Plasma Pharmacokinetics (PK) of LYS228: The volume of distribution at steady state following intravenous administration (Vss)	Calculated based on LYS228 concentration in blood at different time points following drug administration on Day 5	Day 5
Primary	Plasma Pharmacokinetics (PK) of LYS228: The terminal elimination half-life (T 1/2)	Calculated based on LYS228 concentration in blood at different time points following drug administration on Day 5	Day 5
Primary	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)	Calculated based on LYS228 concentration in blood at different time points following drug administration on Day 5	Day 5
Primary	Urine Pharmacokinetics (PK) of LYS228: The amount of drug eliminated in Urine from 0 hours up to 6 hours following intravenus administration (Ae0-6h)	Calculated based on LYS228 concentration in urine at different time points following drug administration on Day 5	Day 5
Primary	Urine Pharmacokinetics (PK) of LYS228: Renal Clearance (CLr)	Calculated based on LYS228 concentration in urine at different time points following drug administration on Day 5	Day 5
Secondary	Change from Baseline of the Microbiological Response at Day 7	Microbiologic success at 7 days after randomization determined by microbial growth in urine culture	Baseline, Day 7