Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| SAATELLITE-2 | Other Identifier | COMBACTE-NET |
Not provided
Not provided
The study was terminated due to administrative reasons
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AR-320 (Suvratoxumab) | Experimental | Participants will receive a single intravenous (IV) dose of suvratoxumab on Day 0 of the study. |
|
| Placebo | Placebo Comparator | Participants will receive a single IV dose of placebo to survatoxumab on Day 0 of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suvratoxumab | Biological | Monoclonal antibody |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 30 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Francois, MD | Centre Hospitalier Universitaire (CHU) de Limoges | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site Bel03 | Haine-Saint-Paul | Belgium | ||||
| Research Site Bel02 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a Phase 3, randomized, placebo-controlled, single-dose study.
Not provided
Not provided
This study is a double-blind, randomized, controlled trial.
| Placebo | Drug | Placebo contains only excipients |
|
| 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 | 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. | 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 | 30 days |
| 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 | 30 days |
| 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 | 90 days |
| 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. | 90 days |
| 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 | 90 days |
| 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. | 90 days |
| Ottignies |
| Belgium |
| Research Site Bel05 | Yvoir | Belgium |
| Research Site Fra05 | Argenteuil | France |
| Research Site Fra16 | La Roche-sur-Yon | France |
| Research Site Fra10 | Le Mans | France |
| Research Site Fra08 | Lille | France |
| Fra06 | Limoges | 87042 | France |
| Research Site Fra07 | Orléans | France |
| Research Site Fra15 | Pierre-Bénite | France |
| Research Site Fra12 | Tours | France |
| Research Site Fra03 | Trévenans | France |
| Research Site GRC01 | Larissa | Greece |
| Research Site ISR03 | Haifa | Israel |
| Research Site ISR05 | Holon | Israel |
| Research Site ISR01 | Ramat Gan | Israel |
| Research Site ISR06 | Safed | Israel |
| Research Site NLD01 | Enschede | Netherlands |
| Research Site NLD03 | Heerlen | Netherlands |
| Research Site NLD02 | Utrecht | Netherlands |
| Research Site SPA04 | Barcelona | Spain |
| Research Site SPA01 | Córdoba | Spain |
| Research Site SPA07 | Madrid | Spain |
| Research Site SPA08 | Santander | Spain |
| Research Site SPA06 | Santiago de Compostela | Spain |
| Research Site SPA03 | Terrassa | Spain |
| Research Site SPA05 | Valencia | Spain |
| ID | Term |
|---|---|
| D053717 | Pneumonia, Ventilator-Associated |
| D013203 | Staphylococcal Infections |
| ID | Term |
|---|---|
| D000077299 | Healthcare-Associated Pneumonia |
| D003428 | Cross Infection |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
Not provided
Not provided
| ID | Term |
|---|---|
| C000600718 | suvratoxumab |
Not provided
Not provided
Not provided