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

Aridis Pharmaceuticals

Status and phase: Terminated; Phase 3

Conditions: Ventilator Associated Pneumonia; Staphylococcus Aureus

Treatments: Drug: Placebo; Biological: Suvratoxumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05331885

AR-320-003

SAATELLITE-2 (Other Identifier)

Details and patient eligibility

About

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

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

Enrollment: 24 patients

Sex: All

Ages: 12 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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24 participants in 2 patient groups, including a placebo group

AR-320 (Suvratoxumab)

Experimental group

Description:

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

Treatment:

Biological: Suvratoxumab

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo