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

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-02

Study Completion Date

2024-07-08

Brief Summary

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

Detailed Description

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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 for S. aureus infections and who are currently free of active S. aureus-related disease but are colonized with S. aureus in the LRT.

Conditions

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Ventilator Associated Pneumonia Staphylococcus Aureus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a Phase 3, randomized, placebo-controlled, single-dose study.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
This study is a double-blind, randomized, controlled trial.

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.

Group Type EXPERIMENTAL

Suvratoxumab

Intervention Type BIOLOGICAL

Monoclonal antibody

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo contains only excipients

Interventions

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Suvratoxumab

Monoclonal antibody

Intervention Type BIOLOGICAL

Placebo

Placebo contains only excipients

Intervention Type DRUG

Other Intervention Names

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AR-320 MEDI4893

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Staphylococcal disease at randomisation;
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
Minimum Eligible Age

12 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aridis Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Research Site Bel02

Ottignies, , Belgium

Site Status

Research Site Bel05

Yvoir, , Belgium

Site Status

Research Site Fra05

Argenteuil, , France

Site Status

Research Site Fra16

La Roche-sur-Yon, , France

Site Status

Research Site Fra10

Le Mans, , France

Site Status

Research Site Fra08

Lille, , France

Site Status

Fra06

Limoges, , France

Site Status

Research Site Fra07

Orléans, , France

Site Status

Research Site Fra15

Pierre-Bénite, , France

Site Status

Research Site Fra12

Tours, , France

Site Status

Research Site Fra03

Trévenans, , France

Site Status

Research Site GRC01

Larissa, , Greece

Site Status

Research Site ISR03

Haifa, , Israel

Site Status

Research Site ISR05

Holon, , Israel

Site Status

Research Site ISR01

Ramat Gan, , Israel

Site Status

Research Site ISR06

Safed, , Israel

Site Status

Research Site NLD01

Enschede, , Netherlands

Site Status

Research Site NLD03

Heerlen, , Netherlands

Site Status

Research Site NLD02

Utrecht, , Netherlands

Site Status

Research Site SPA04

Barcelona, , Spain

Site Status

Research Site SPA01

Córdoba, , Spain

Site Status

Research Site SPA07

Madrid, , Spain

Site Status

Research Site SPA08

Santander, , Spain

Site Status

Research Site SPA06

Santiago de Compostela, , Spain

Site Status

Research Site SPA03

Terrassa, , Spain

Site Status

Research Site SPA05

Valencia, , Spain

Site Status

Countries

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Belgium France Greece Israel Netherlands Spain

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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