YS228 PK, clinical response, safety and tolerability in patients with complicated urinary tract infection (cUTI)

Phase 1

• Conditions: complicated Urinary Tract Infection (cUTI); MedDRA version: 20.0Level: PTClassification code 10054088Term: Urinary tract infection bacterialSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.1Level: LLTClassification code 10079982Term: Complicated lower urinary tract infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2017-002292-26-CZ
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-05
• Last Update Posted: 12 November 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

-Male and female patients 18 to 65 years of age, and after interim analysis of eight
patients inclusion of patients up to 70 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 protocol defined 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

-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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: •To evaluate the plasma and urine pharmacokinetics of LYS228 in patients with cUTI.<br>•To evaluate the clinical response to LYS228 compared to standard of care antibiotics for treating patients with cUTI<br>;Secondary Objective: •To evaluate the safety and tolerability of LYS228 in patients with cUTI<br>•To evaluate the microbiological response to LYS228 compared to standard of care antibiotics for treating patients with cUTI<br>;Primary end point(s): •Plasma PK parameters (AUCtau, Cmax, Tmax, CL, Vss, T1/2, %fT>MIC)<br>•Urine Ae0-6h and CLr<br>•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<br>Baseline, Day 7 for clinical endpoint

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Adverse events;Clinical laboratory tests; Vital signs<br>•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<br>- Baseline, Day 7 for microbiological success