A Human Monoclonal Antibody Against Staphylococcus Aureus Alpha Toxin in Mechanically Ventilated Adult Subjects - 2 (SAATELLITE-2)
Primary Purpose
Ventilator Associated Pneumonia, Staphylococcus Aureus
Status
Recruiting
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Suvratoxumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Ventilator Associated Pneumonia
Eligibility Criteria
Inclusion Criteria:
- Colonized with Staphylococcus aureus;
- Expected to require prolonged intubation and mechanical ventilation, without any evidence of active pneumonia.
Exclusion Criteria:
- 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
Sites / Locations
- Research SiteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
AR-320 (Suvratoxumab)
Placebo
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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.
Number of Participants with Nosocomial all-cause pneumonia or death 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 cause, or death following administration of study drug through 30 days post dose
Number of Participants with Nosocomial S. aureus pneumonia 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
Number of Participants with Nosocomial S. aureus pneumonia through 90 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
Suvratoxumab Maximum Observed Serum Concentration (Cmax)
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.
Suvratoxumab Area under the Plasma Concentration-Time Curve (AUC)
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
Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to Suvratoxumab
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.
Full Information
NCT ID
NCT05331885
First Posted
April 1, 2022
Last Updated
February 1, 2023
Sponsor
Aridis Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05331885
Brief Title
A Human Monoclonal Antibody Against Staphylococcus Aureus Alpha Toxin in Mechanically Ventilated Adult Subjects - 2
Acronym
SAATELLITE-2
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 2, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aridis Pharmaceuticals, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Clinical trial looking at safety and efficacy of suvratoxumab in prevention of pneumonia caused by Staphylococcus aureus in high-risk patients
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilator Associated Pneumonia, Staphylococcus Aureus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
This is a Phase 3, randomized, placebo-controlled, single-dose study.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
This study is a double-blind, randomized, controlled trial.
Allocation
Randomized
Enrollment
564 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AR-320 (Suvratoxumab)
Arm Type
Experimental
Arm Description
Participants will receive a single intravenous (IV) dose of suvratoxumab on Day 0 of the study.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive a single IV dose of placebo to survatoxumab on Day 0 of the study.
Intervention Type
Biological
Intervention Name(s)
Suvratoxumab
Other Intervention Name(s)
AR-320, MEDI4893
Intervention Description
Monoclonal antibody
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo contains only excipients
Primary Outcome Measure Information:
Title
Incidence of nosocomial all-cause pneumonia through 30 days post dose
Description
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 Outcome Measure Information:
Title
Number of participants with TEAE at 30 days
Description
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
Title
Number of participants with TESAE at 90 days
Description
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
Title
Number of participants with TEAESI at 90 days
Description
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
Title
Number of Participants with Nosocomial all-cause pneumonia or death through 30 days post dose
Description
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
Time Frame
30 days
Title
Number of Participants with Nosocomial S. aureus pneumonia through 30 days post dose
Description
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
Time Frame
30 days
Title
Number of Participants with Nosocomial S. aureus pneumonia through 90 days post dose
Description
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
Time Frame
90 days
Title
Suvratoxumab Maximum Observed Serum Concentration (Cmax)
Description
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.
Time Frame
90 days
Title
Suvratoxumab Area under the Plasma Concentration-Time Curve (AUC)
Description
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
Time Frame
90 days
Title
Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to Suvratoxumab
Description
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.
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Colonized with Staphylococcus aureus;
Expected to require prolonged intubation and mechanical ventilation, without any evidence of active pneumonia.
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hasan S Jafri, MD, FAAP
Phone
+1-408-385-1742
Email
clinicaltrial@aridispharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno Francois, MD
Organizational Affiliation
Centre Hospitalier Universitaire (CHU) de Limoges
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Limoges
ZIP/Postal Code
87042
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Site
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Human Monoclonal Antibody Against Staphylococcus Aureus Alpha Toxin in Mechanically Ventilated Adult Subjects - 2
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