Last updated on January 2020

Adjunctive Therapy to Antibiotics in the Treatment of S. Aureus Ventilator-Associated Pneumonia With AR-301


Brief description of study

AR-301 is being evaluated as an adjunctive treatment of ventilator-associated pneumonia (VAP) due to Staphylococcus aureus (S. aureus) in combination with standard of care (SOC) antibiotic therapy in patients with confirmed S. aureus infection.

Detailed Study Description

This study is an international, multicenter, prospective, randomized, double blind, placebo controlled, parallel design protocol in patients with Ventilator-Associated Pneumonia (VAP) caused by S. aureus.

Patients with a documented diagnosis of pneumonia due to S. aureus, and require ICU care, who have been intubated (or have a tracheostomy tube in place) and mechanically ventilated for at least 48 hours are eligible for screening.

In total, approximately 240 subjects will be randomized 1-1 to be treated with placebo plus standard of care (SOC) or AR-301 (20 mg/kg) plus SOC in this Phase 3 study.

Study subjects will receive a single treatment dose at Day 0 in addition to SOC antibiotic treatment, and then enter a safety, efficacy and PK study period for a total study duration of 28 days. The selection of SOC antibiotics is made in accordance with local best practices at the discretion of the investigator.

Clinical Study Identifier: NCT03816956

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University of California

Sacramento, CA United States
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Hospital Felicio Rocho

Belo Horizonte, Brazil
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SINACOR

Culiacán, Mexico
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City Clinical Hospital No.5

Barnaul, Russian Federation
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City Clinical Hospital # 1

Novosibirsk, Russian Federation
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City Clinical Hospital #2

Novosibirsk, Russian Federation
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City Hospital of Emergency#2

Novosibirsk, Russian Federation
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Zhukovsky City Clinical Hospital

Zhukovskiy, Russian Federation
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Helen Joseph Hospital

Auckland Park, South Africa
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Johese Clinical Research

Centurion, South Africa
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Netcare Milpark Hospital

Johannesburg, South Africa
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JOHESE Clinical research

Midstream, South Africa
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Mediclinic Worcester

Worcester, South Africa
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Regional Clinical Hospital

Ivano-Frankivs'k, Ukraine
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Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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