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
Location: See all (27) locations...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
Clinical trial looking at safety and efficacy of suvratoxumab in prevention of pneumonia caused by Staphylococcus aureus in high-risk patients
Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 65
Healthy Volunteers: f
View:
• Colonized with Staphylococcus aureus;
• Expected to require prolonged intubation and mechanical ventilation, without any evidence of active pneumonia.
Locations
Other Locations
Belgium
Research Site Bel03
Haine-saint-paul
Research Site Bel02
Ottignies
Research Site Bel05
Yvoir
France
Research Site Fra05
Argenteuil
Research Site Fra16
La Roche-sur-yon
Research Site Fra10
Le Mans
Research Site Fra08
Lille
Fra06
Limoges
Research Site Fra07
Orléans
Research Site Fra15
Pierre-bénite
Research Site Fra12
Tours
Research Site Fra03
Trévenans
Greece
Research Site GRC01
Larissa
Israel
Research Site ISR03
Haifa
Research Site ISR05
Holon
Research Site ISR01
Ramat Gan
Research Site ISR06
Safed
Netherlands
Research Site NLD01
Enschede
Research Site NLD03
Heerlen
Research Site NLD02
Utrecht
Spain
Research Site SPA04
Barcelona
Research Site SPA01
Córdoba
Research Site SPA07
Madrid
Research Site SPA08
Santander
Research Site SPA06
Santiago De Compostela
Research Site SPA03
Terrassa
Research Site SPA05
Valencia
Time Frame
Start Date: 2022-09-02
Completion Date: 2024-07-08
Participants
Target number of participants: 24
Treatments
Experimental: AR-320 (Suvratoxumab)
Participants will receive a single intravenous (IV) dose of suvratoxumab on Day 0 of the study.
Placebo_comparator: Placebo
Participants will receive a single IV dose of placebo to survatoxumab on Day 0 of the study.
Authors
Related Therapeutic Areas
Sponsors
Leads: Aridis Pharmaceuticals, Inc.