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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-19

Study Completion Date

2019-10-28

Brief Summary

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

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Detailed Description

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Conditions

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Complicated Urinary Tract Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

A blinded evaluator will perform the safety and efficacy assessments

Study Groups

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LYS228

IV infusion

Group Type EXPERIMENTAL

LYS228

Intervention Type DRUG

LYS228 IV infusion

Standard of care

IV infusion of standard of care antibiotics for at least 5 days

Group Type ACTIVE_COMPARATOR

Standard of care therapy

Intervention Type DRUG

IV infusion of standard of care antibiotics

Interventions

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LYS228

LYS228 IV infusion

Intervention Type DRUG

Standard of care therapy

IV infusion of standard of care antibiotics

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No