A Human Monoclonal Antibody Against Staphylococcus Aureus Alpha Toxin in Mechanically Ventilated Adult Subjects - 2
NCT ID: NCT05331885
Last Updated: 2025-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
24 participants
INTERVENTIONAL
2022-09-02
2024-07-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AR-320 (Suvratoxumab)
Participants will receive a single intravenous (IV) dose of suvratoxumab on Day 0 of the study.
Suvratoxumab
Monoclonal antibody
Placebo
Participants will receive a single IV dose of placebo to survatoxumab on Day 0 of the study.
Placebo
Placebo contains only excipients
Interventions
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Suvratoxumab
Monoclonal antibody
Placebo
Placebo contains only excipients
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Expected to require prolonged intubation and mechanical ventilation, without any evidence of active pneumonia.
Exclusion Criteria
2. Lung injury score consistent with pneumonia;
3. Chronic tracheostomy patients;
4. The study subject is moribund
5. Receipt of anti- S. aureus systemic antibiotics
6. Active pulmonary disease
12 Years
65 Years
ALL
No
Sponsors
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Aridis Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Francois, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Universitaire (CHU) de Limoges
Locations
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Research Site Bel03
Haine-Saint-Paul, , Belgium
Research Site Bel02
Ottignies, , Belgium
Research Site Bel05
Yvoir, , Belgium
Research Site Fra05
Argenteuil, , France
Research Site Fra16
La Roche-sur-Yon, , France
Research Site Fra10
Le Mans, , France
Research Site Fra08
Lille, , France
Fra06
Limoges, , France
Research Site Fra07
Orléans, , France
Research Site Fra15
Pierre-Bénite, , France
Research Site Fra12
Tours, , France
Research Site Fra03
Trévenans, , France
Research Site GRC01
Larissa, , Greece
Research Site ISR03
Haifa, , Israel
Research Site ISR05
Holon, , Israel
Research Site ISR01
Ramat Gan, , Israel
Research Site ISR06
Safed, , Israel
Research Site NLD01
Enschede, , Netherlands
Research Site NLD03
Heerlen, , Netherlands
Research Site NLD02
Utrecht, , Netherlands
Research Site SPA04
Barcelona, , Spain
Research Site SPA01
Córdoba, , Spain
Research Site SPA07
Madrid, , Spain
Research Site SPA08
Santander, , Spain
Research Site SPA06
Santiago de Compostela, , Spain
Research Site SPA03
Terrassa, , Spain
Research Site SPA05
Valencia, , Spain
Countries
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Other Identifiers
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SAATELLITE-2
Identifier Type: OTHER
Identifier Source: secondary_id
AR-320-003
Identifier Type: -
Identifier Source: org_study_id
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