NCT05331885

A Human Monoclonal Antibody Against Staphylococcus Aureus Alpha Toxin in Mechanically Ventilated Adult Subjects - 2

A Phase 3, Randomized, Double-blind, Placebo-controlled, Single-dose Study to Evaluate the Efficacy and Safety of Suvratoxumab in Mechanically Ventilated Adults and Adolescents for the Prevention of Nosocomial Pneumonia

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Aridis Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 12 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Clinical trial looking at safety and efficacy of suvratoxumab in prevention of pneumonia caused by Staphylococcus aureus in high-risk patients

Detailed description

This is a Phase 3, randomized, double-blind, placebo-controlled study evaluating the efficacy of a single IV dose of suvratoxumab in mechanically ventilated subjects in the ICU who are at high risk for S. aureus infections and who are currently free of active S. aureus-related disease but are colonized with S. aureus in the LRT.

Conditions

• Ventilator Associated Pneumonia
• Staphylococcus Aureus

Interventions

Type	Name	Description
BIOLOGICAL	Suvratoxumab	Monoclonal antibody
DRUG	Placebo	Placebo contains only excipients

Timeline

• Start date: 2022-09-02
• Primary completion: 2024-07-08
• Completion: 2024-07-08
• First posted: 2022-04-18
• Last updated: 2025-03-24

Locations

27 sites across 6 countries: Belgium, France, Greece, Israel, Netherlands, Spain

Regulatory

• FDA-regulated drug study