Status:
TERMINATED
A Human Monoclonal Antibody Against Staphylococcus Aureus Alpha Toxin in Mechanically Ventilated Adult Subjects - 2
Lead Sponsor:
Aridis Pharmaceuticals, Inc.
Conditions:
Ventilator Associated Pneumonia
Staphylococcus Aureus
Eligibility:
All Genders
12-65 years
Phase:
PHASE3
Brief 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 fo...
Eligibility Criteria
Inclusion
- Colonized with Staphylococcus aureus;
- Expected to require prolonged intubation and mechanical ventilation, without any evidence of active pneumonia.
Exclusion
- Staphylococcal disease at randomisation;
- Lung injury score consistent with pneumonia;
- Chronic tracheostomy patients;
- The study subject is moribund
- Receipt of anti- S. aureus systemic antibiotics
- Active pulmonary disease
Key Trial Info
Start Date :
September 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 8 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05331885
Start Date
September 2 2022
End Date
July 8 2024
Last Update
March 24 2025
Active Locations (27)
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1
Research Site Bel03
Haine-Saint-Paul, Belgium
2
Research Site Bel02
Ottignies, Belgium
3
Research Site Bel05
Yvoir, Belgium
4
Research Site Fra05
Argenteuil, France