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

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ClinicalTrials.gov Identifier: NCT03377426
Recruitment Status : Withdrawn (The trial was terminated due to an out-licensing agreement after the new sponsor did not wish to continue the trial)
First Posted : December 19, 2017
Last Update Posted : October 26, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:
The purpose of the study is to evaluate whether LYS228 can be developed for the treatment of complicated urinary tract infections

Condition or disease Intervention/treatment Phase
Complicated Urinary Tract Infections Drug: LYS228 Drug: Standard of care therapy Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: A blinded evaluator will perform the safety and efficacy assessments
Primary Purpose: Basic Science
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
Estimated Study Start Date : October 19, 2018
Estimated Primary Completion Date : October 28, 2019
Estimated Study Completion Date : October 28, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: LYS228
IV infusion
 Drug: LYS228
LYS228 IV infusion
Active Comparator: Standard of care
IV infusion of standard of care antibiotics for at least 5 days
 Drug: Standard of care therapy
IV infusion of standard of care antibiotics


Outcome Measures
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Primary Outcome Measures :
  1. Change from Baseline of the Clinical Response at Day 7 [ Time Frame: Baseline, Day 7 ]
    Clinical success at 7 days after randomization determined by signs and symptoms of infection and the need for additional antibiotics

  2. Plasma Pharmacokinetics (PK) of LYS228: Area Under the Plasma Concentration-time Curve from time zero to the end of dosing interval tau (AUCtau) [ Time Frame: Day 5 ]
    Calculated based on LYS228 concentration in blood at different time points following drug administration on Day 5

  3. Plasma Pharmacokinetics (PK) of LYS228: The observed maximum plasma concentration following drug administration (Cmax) [ Time Frame: Day 5 ]
    Calculated based on LYS228 concentration in blood at different time points following drug administration on Day 5

  4. Plasma Pharmacokinetics (PK) of LYS228: The time to reach the maximum concentration after drug administration (Tmax) [ Time Frame: Day 5 ]
    Calculated based on LYS228 concentration in blood at different time points following drug administration on Day 5

  5. Plasma Pharmacokinetics (PK) of LYS228: The systemic (or total body) clearance from plasma following intravenous administration (CL) [ Time Frame: Day 5 ]
    Calculated based on LYS228 concentration in blood at different time points following drug administration on Day 5

  6. Plasma Pharmacokinetics (PK) of LYS228: The volume of distribution at steady state following intravenous administration (Vss) [ Time Frame: Day 5 ]
    Calculated based on LYS228 concentration in blood at different time points following drug administration on Day 5

  7. Plasma Pharmacokinetics (PK) of LYS228: The terminal elimination half-life (T 1/2) [ Time Frame: Day 5 ]
    Calculated based on LYS228 concentration in blood at different time points following drug administration on Day 5

  8. 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) [ Time Frame: Day 5 ]
    Calculated based on LYS228 concentration in blood at different time points following drug administration on Day 5

  9. Urine Pharmacokinetics (PK) of LYS228: The amount of drug eliminated in Urine from 0 hours up to 6 hours following intravenus administration (Ae0-6h) [ Time Frame: Day 5 ]
    Calculated based on LYS228 concentration in urine at different time points following drug administration on Day 5

  10. Urine Pharmacokinetics (PK) of LYS228: Renal Clearance (CLr) [ Time Frame: Day 5 ]
    Calculated based on LYS228 concentration in urine at different time points following drug administration on Day 5


Secondary Outcome Measures :
  1. Change from Baseline of the Microbiological Response at Day 7 [ Time Frame: Baseline, Day 7 ]
    Microbiologic success at 7 days after randomization determined by microbial growth in urine culture


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03377426


Locations
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United States, Michigan
Novartis Investigative Site
Detroit, Michigan, United States, 48202
United States, New Jersey
Novartis Investigative Site
Newark, New Jersey, United States, 07102
United States, Washington
Novartis Investigative Site
Seattle, Washington, United States, 98195
Denmark
Novartis Investigative Site
Odense, Denmark, 5000
Greece
Novartis Investigative Site
Athens, Greece, 115 27
Sponsors and Collaborators
Novartis Pharmaceuticals
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03377426    
Other Study ID Numbers: CLYS228X2201
First Posted: December 19, 2017    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Urinary tract infection, LYS228, beta-lactam antibiotics, creatinine clearance, Enterobactericeae
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Urinary Tract Infections
Disease Attributes
Pathologic Processes
 Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases