drugset / Trial / NCT03816956

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

NCT03816956 ↗

Phase 3 Completed 174 enrolled Aridis Pharmaceuticals, Inc.
RandomizedParallel-groupTriple-blindTreatment

Summary

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.

Timeline

Start
2019-05-03
Primary completion
2022-10-28
Completion
2022-10-28

Outcome

Missed primary endpoint

release “Clinical cure at Day 21 was 68.9% (42/61 patients) for AR-301 + SOC versus 57.6% (34/59) for SOC alone, (efficacy difference or absolute efficacy: 11.3%, [p= 0.23]).” aridispharma.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject tosatoxumab Monoclonal antibody 20 mg/kg Intravenous