complicated Urinary Tract Infection (cUTI) MedDRA version: 20.0 Level: PT Classification code 10054088 Term: Urinary tract infection bacterial System Organ Class: 10021881 - Infections and infestations MedDRA version: 20.1 Level: LLT Classification code 10079982 Term: Complicated lower urinary tract infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Code: LYS228
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Not established
CAS Number: N/A
Current Sponsor code: LYS228
Other descriptive name: LYS228
Concentratio
locally
sourced
Product Name: Piperacillin/tazobactam
Pharmaceutical Form: Powder and solvent for solution for injection/infusion
INN or Proposed INN: PIPERACILLIN
Other descriptive name: PIPERACILLIN
commercially available meropenem
locally sourced
Product Name: Meropenem
Product Code: J01DH02
Pharmaceutical Form: Powder and solvent for solution for injection/infusion
INN or Proposed INN: MEROPENEM
CAS Number: 96036-03-2
Other de
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Male and female patients 18 to 65 years of age, and after interim analysis of eight patients inclusion of patients up 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) -Other inclusion criteria may apply Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 42 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 18
Exclusion criteria
Exclusion criteria: -Urine Gram stain that demonstrated that a Gram-positive organism was present, or if urine culture results were available, demonstrated Grampositive organisms were present at =105 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 at enrollment and demonstrating fungal UTI with colony count >103 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 -Other protocol-defined exclusion criteria may apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To evaluate the plasma and urine pharmacokinetics of LYS228 in patients with cUTI. • To evaluate the clinical response to LYS228 compared to standard of care antibiotics for treating patients with cUTI ;Secondary Objective: • To evaluate the safety and tolerability of LYS228 in patients with cUTI • To evaluate the microbiological response to LYS228 compared to standard of care antibiotics for treating patients with cUTI ;Primary end point(s): • Plasma PK parameters (AUCtau, Cmax, Tmax, CL, Vss, T1/2, %fT>MIC) • Urine Ae0-6h and CLr • Clinical success after completion of therapy (End of Study) determined by signs, and symptoms.;Timepoint(s) of evaluation of this end point: Day 5 for PK endpoints Baseline, Day 7 for clinical endpoint | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Adverse events;Clinical laboratory tests; Vital signs • Microbiological success after completion of therapy (End of Study) determined by quantitative urinary culture;Timepoint(s) of evaluation of this end point: - Daily for safety and tolerability endpoints - Baseline, Day 7 for microbiological success | — |
Countries
Czech Republic, Denmark, Germany, Greece, United States
Contacts
Public ContactVeronique Schaaf
Novartis (Hellas) S.A.C.I.
Outcome results
None listed