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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Written Informed Consent given by the patient or, if not possible, by a legally acceptable representative and/or an independent physician as authorized by the competent ethics committee (EC) or independent review board (IRB) and local regulations.
✓. To be at least 18 years of age. Taiwan only: To be at least 20 years of age. South Korea only: To be at least 19 years of age.
✓. Treated in an ICU at the time of enrollment.
✓. Endotracheal tube in place (tracheostomy is allowed).
✓. The patient is mechanically ventilated for at least 48 hours.
✓. Diagnosis of pneumonia based on the following criteria (a, b, and c, all must be met):
✓. One definitive chest X-ray diagnostic of pneumonia within 48 hours,
✓. Hypoxemia based on PaO2/FiO2.
Exclusion criteria
✕. The subject is unlikely to survive for the study duration despite delivery of adequate antibiotics and supportive care for treatment of S. aureus pneumonia.
✕. Effective antibacterial drug therapy for the index pneumonia administered continuously for 48 hours or more prior to initiation of study treatment. Effective antibiotics would include those typically used to treat S. aureus.
✕. Plasmapheresis (ongoing or planned), extracorporeal membrane oxygenation (ECMO) or any procedure that would remove/filter out the monoclonal antibody/study drug.
What they're measuring
1
A comparison of Clinical Cure Rates of standard of care (SOC) alone and SOC with AR-301
Timeframe: 21 days
2
Safety of AR-301 by treatment-emergent adverse events assessed by changes between treatment and placebo as assessed by the Principal Investigator
Timeframe: 21 Days
3
Tolerability of AR-301 measured by the number of participants with treatment-emergent adverse events classified using CTCAE v 5.0
✕. Liver dysfunction with a Child Pugh C score \> 9 (Child Pugh score of A or B are acceptable at discretion of the Principal Investigator \[PI\]).
✕. Pulmonary disease that precludes evaluation of a therapeutic response (such as lung cancer resulting in bronchial obstruction or on the same side as the pneumonia, active tuberculosis, cystic fibrosis, granulomatous disease, fungal pulmonary infection, lung abscess, pleural empyema or post obstructive pneumonia).
✕. Patient has received intravenous (IV) immunoglobulin therapy within 3 months prior to the Screening Visit.