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

Phase 3TerminatedNCT05331885

Aridis Pharmaceuticals, Inc.24 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Ventilator Associated Pneumonia Staphylococcus Aureus

Interventions

SuvratoxumabBIOLOGICAL

Monoclonal antibody

PlaceboDRUG

Placebo contains only excipients

Eligibility

Sex: ALLMin age: 12 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (27)

Research Site Bel03

Haine-Saint-Paul, Belgium

Research Site Bel02

Outcomes

Primary Outcomes

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

Time frame: 30 days

Secondary Outcomes

Number of participants with TEAE at 30 days

Treatment emergent adverse events (TEAE) are those adverse events (AEs, any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship) that occur or worsen during the treatment period, i.e., after the administration of study drug, through 30 days post dose

Time frame: 30 days

Number of participants with TESAE at 90 days

Treatment emergent serious adverse events (TESAE) are serious adverse events (SAEs, AEs resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience; persistent or significant disability/incapacity; congenital anomaly) that, as TEAEs, are present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug, through 90 days

Time frame: 90 days

Number of participants with TEAESI at 90 days

A TEAE of special interest (TEAESI) is an AE of scientific and medical interest specific to understanding of the study drug and may have required close monitoring and rapid communication by the investigator to the sponsor. An AESI may have been serious or non-serious. The time-frame is 90 days.

Time frame: 90 days

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

Data from ClinicalTrials.gov

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