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-GR
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-07
• Last Update Posted: 22 October 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 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

-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