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

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

Ventilator Associated Pneumonia

Staphylococcus Aureus

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.

Suvratoxumab

Placebo

A Phase 3, Randomized, Double-blind, Placebo-controlled, Single-dose Study to Evaluate the Efficacy and Safety of Suvratoxumab in Mechanically Ventilated Adults and Adolescents for the Prevention of Nosocomial Pneumonia

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

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

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

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.

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 cause, or death following administration of study drug through 30 days post dose

S. aureus pneumonia is based on clinical, radiographic, and microbiologic criteria. The percent reduction of the incidence of (% of patients with) nosocomial S. aureus pneumonia following administration of study drug through 30 days post dose

S. aureus pneumonia is based on clinical, radiographic, and microbiologic criteria. The percent reduction of the incidence of (% of patients with) nosocomial S. aureus pneumonia following administration of study drug through 90 days post dose

Maximum Observed Serum Concentration (Cmax) of suvratoxumab at Day 0 (Pre-dose, end of the infusion, 8 and 24 hours post dose), and on Days 7, 30 and 90. At Day 90 only for a subset of patients.

the area under the plasma concentration-time curve (AUC) will be measured from time 0 to Day 30 (AUC0-30), in all study subjects, and AUC from time 0 to Day 90 (AUC0-90) for a subset of subjects

The incidence of (number of patients with) positive anti-drug antibodies (ADA) titer to suvratoxumab will be assessed and summarized by number and percentage of subjects that are ADA positive at predose, Day 30 in all subjects and Day 90 in a subset of patients.

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

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

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

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status