drugset / Trial / NCT03816956
Adjunctive Therapy to Antibiotics in the Treatment of S. Aureus Ventilator-Associated Pneumonia With AR-301
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | tosatoxumab | Monoclonal antibody | 20 mg/kg | Intravenous |