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Suvratoxumab for prevention of nosocomial pneumonia in ventilated patients
NCT05331885Phase 3
Key facts
- Status
- Terminated
- Start
- Sep 2022
- Primary completion
- Jul 2024
- Countries
- 6
- Sponsor
- Aridis Pharmaceuticals, Inc.
- Modality
- Monoclonal Antibodies
- Drugs
- Suvratoxumab
- Conditions
- hospital-acquired pneumonia (HAP)Staphylococcus aureus pneumonia
01
Overview
Phase 3, randomised, double-blind trial in hospital-acquired pneumonia (HAP) and Staphylococcus aureus pneumonia comparing Suvratoxumab with Placebo (2 arms). Primary endpoint: Incidence of nosocomial all-cause pneumonia through 30 days post dose. Started Sep 2022; status: terminated.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Suvratoxumab
Single IV dose of Suvratoxumab
Placebo
Single IV dose of Placebo
03
Who it enrols
Mechanically ventilated adults and adolescents colonized with Staphylococcus aureus in the lower respiratory tract but without active pneumonia.
04
Endpoints
Primary
Incidence of nosocomial all-cause pneumonia through 30 days post dose
Secondary
Number of participants with Treatment-Emergent Adverse Events
Number of participants with Treatment-Emergent Serious Adverse Events
Number of participants with Treatment-Emergent Adverse Events of Special Interest
Number of Participants with Nosocomial all-cause pneumonia or death
Number of Participants with Nosocomial S. aureus pneumonia
Suvratoxumab Maximum Observed Serum Concentration
Suvratoxumab Area under the Plasma Concentration-Time Curve
Number of Participants With Positive Anti-Drug Antibodies
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