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

• ClinicalTrials.gov Identifier: NCT05331885
• Recruitment Status: Recruiting
• First Posted: April 18, 2022
• Last Update Posted: February 3, 2023
• Sponsor: Aridis Pharmaceuticals, Inc.
• Information provided by (Responsible Party): Aridis Pharmaceuticals, Inc.

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

Condition or disease	Intervention/treatment	Phase
Ventilator Associated Pneumonia; Staphylococcus Aureus	Biological: Suvratoxumab; Drug: Placebo	Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 564 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: This is a Phase 3, randomized, placebo-controlled, single-dose study.
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: This study is a double-blind, randomized, controlled trial.
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: September 2, 2022
• Estimated Primary Completion Date: October 2023
• Estimated Study Completion Date: June 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: AR-320 (Suvratoxumab); Participants will receive a single intravenous (IV) dose of suvratoxumab on Day 0 of the study.	Biological: Suvratoxumab; Monoclonal antibody; Other Names: AR-320; MEDI4893
Placebo Comparator: Placebo; Participants will receive a single IV dose of placebo to survatoxumab on Day 0 of the study.	Drug: Placebo; Placebo contains only excipients

Outcome Measures

Primary Outcome Measures :

1. Incidence of nosocomial all-cause pneumonia through 30 days post dose [ Time Frame: 30 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 identified etiology, following administration of study drug through 30 days post dose

Secondary Outcome Measures :

1. Number of participants with TEAE at 30 days [ Time Frame: 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
2. Number of participants with TESAE at 90 days [ Time Frame: 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
3. Number of participants with TEAESI at 90 days [ Time Frame: 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.
4. Number of Participants with Nosocomial all-cause pneumonia or death through 30 days post dose [ Time Frame: 30 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
5. Number of Participants with Nosocomial S. aureus pneumonia through 30 days post dose [ Time Frame: 30 days ]
   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
6. Number of Participants with Nosocomial S. aureus pneumonia through 90 days post dose [ Time Frame: 90 days ]
   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
7. Suvratoxumab Maximum Observed Serum Concentration (Cmax) [ Time Frame: 90 days ]
   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.
8. Suvratoxumab Area under the Plasma Concentration-Time Curve (AUC) [ Time Frame: 90 days ]
   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
9. Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to Suvratoxumab [ Time Frame: 90 days ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 12 Years to 65 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Hasan S Jafri, MD, FAAP; +1-408-385-1742; clinicaltrial@aridispharma.com

Locations

France

Research Site; Recruiting

Limoges, France, 87042

Contact: Research Site

Sponsors and Collaborators

Aridis Pharmaceuticals, Inc.

Investigators

• Principal Investigator: Bruno Francois, MD; Centre Hospitalier Universitaire (CHU) de Limoges

More Information

• Responsible Party: Aridis Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT05331885
• Other Study ID Numbers: AR-320-003; SAATELLITE-2 ( Other Identifier: COMBACTE-NET )
• First Posted: April 18, 2022
• Last Update Posted: February 3, 2023
• Last Verified: February 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Pneumonia; Pneumonia, Ventilator-Associated; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Healthcare-Associated Pneumonia; Cross Infection; Iatrogenic Disease; Disease Attributes; Pathologic Processes