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

NCT05331885 | Terminated Phase 3 DMC FDA Drug

• 2 other identifiers: AR-320-003SAATELLITE-2
• Study Type: interventional
• Target: 24
• Locations: 6 countries
• Sites: 27

Brief Summary

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

Conditions

Ventilator Associated Pneumonia; Staphylococcus Aureus

Outcome Measures

Primary Outcomes (1)

• Incidence of nosocomial all-cause pneumonia through 30 days post dose

  All-cause pneumonia is based on clinical, radiographic, and microbiologic criteria. The percent reduction of the incidence of (% of patients with) nosocomial all-cause pneumonia, regardless of identified etiology, following administration of study drug through 30 days post dose

  30 days

Secondary Outcomes (9)

• Number of participants with TEAE at 30 days

  30 days

• Number of participants with TESAE at 90 days

  90 days

• Number of participants with TEAESI at 90 days

  90 days

• Number of Participants with Nosocomial all-cause pneumonia or death through 30 days post dose

  30 days

• Number of Participants with Nosocomial S. aureus pneumonia through 30 days post dose

  30 days

Study Arms (2)

AR-320 (Suvratoxumab)

EXPERIMENTAL

Participants will receive a single intravenous (IV) dose of suvratoxumab on Day 0 of the study.

Biological: Suvratoxumab

Placebo

PLACEBO COMPARATOR

Participants will receive a single IV dose of placebo to survatoxumab on Day 0 of the study.

Drug: Placebo

Interventions

Suvratoxumab BIOLOGICAL

Monoclonal antibody

Also known as: AR-320, MEDI4893

AR-320 (Suvratoxumab)

Placebo DRUG

Placebo contains only excipients

Placebo

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Colonized with Staphylococcus aureus;
• Expected to require prolonged intubation and mechanical ventilation, without any evidence of active pneumonia.

You may not qualify if:

• 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

Sponsors & Collaborators

• Aridis Pharmaceuticals, Inc.: lead

Study Sites (27)

Research Site Bel03

Haine-Saint-Paul, Belgium

Location

Research Site Bel02

Ottignies, Belgium

Location

Research Site Bel05

Yvoir, Belgium

Location

Research Site Fra05

Argenteuil, France

Location

Research Site Fra16

La Roche-sur-Yon, France

Location

Research Site Fra10

Le Mans, France

Location

Research Site Fra08

Lille, France

Location

Fra06

Limoges, 87042, France

Location

Research Site Fra07

Orléans, France

Location

Research Site Fra15

Pierre-Bénite, France

Location

Research Site Fra12

Tours, France

Location

Research Site Fra03

Trévenans, France

Location

Research Site GRC01

Larissa, Greece

Location

Research Site ISR03

Haifa, Israel

Location

Research Site ISR05

Holon, Israel

Location

Research Site ISR01

Ramat Gan, Israel

Location

Research Site ISR06

Safed, Israel

Location

Research Site NLD01

Enschede, Netherlands

Location

Research Site NLD03

Heerlen, Netherlands

Location

Research Site NLD02

Utrecht, Netherlands

Location

Research Site SPA04

Barcelona, Spain

Location

Research Site SPA01

Córdoba, Spain

Location

Research Site SPA07

Madrid, Spain

Location

Research Site SPA08

Santander, Spain

Location

Research Site SPA06

Santiago de Compostela, Spain

Location

Research Site SPA03

Terrassa, Spain

Location

Research Site SPA05

Valencia, Spain

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated; Staphylococcal Infections

Interventions

suvratoxumab

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Study Officials

• Francois, MD

  Centre Hospitalier Universitaire (CHU) de Limoges

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study is a double-blind, randomized, controlled trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a Phase 3, randomized, placebo-controlled, single-dose study.

Study Record Dates

• First Submitted: April 1, 2022
• First Posted: April 18, 2022
• Study Start: September 2, 2022
• Primary Completion: July 8, 2024
• Study Completion: July 8, 2024
• Last Updated: March 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1); FR (9); BE (3); IL (4); NL (3); ES (7)