Staphylococcus aureus
Conditions
Interventions
Single-dose of 5000 mg suvratoxumab or placebo intravenously administered at D0
of V2.
Sponsors
Aridis Pharmaceuticals, Inc.
Eligibility
Age
12 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Adult (18 [unless otherwise specified by local Country laws] to 65 years of age) or Adolescent (12 to
Exclusion criteria
Exclusion criteria: 1. The study subject is moribund or unlikely to survive for a week post randomization despite delivery of adequate antibiotics and supportive care based on clinical judgement by the Principal Investigator (PI). 2. Acute confirmed or suspected active S. aureus disease at study enrolment and investigational product dosing (colonization is acceptable as per inclusion criterion #4). 3. Active pulmonary disease that would impair the ability to diagnose pneumonia, such as active tuberculosis or fungal disease, obstructing lung cancer, large empyema, cystic fibrosis, or acute respiratory distress syndrome with lung "white out". 4. Receipt of anti- S. aureus systemic antibiotics for > 48 hours within 72 hours prior to randomization that are considered active against the S. aureus strain with which the subject is colonized or anticipated ongoing receipt of anti- S. aureus systemic antibiotics. 5. Acute Physiology and Chronic Health Evaluation (APACHE)-II score >= 25 (if Glasgow Coma Scale [GCS] score is > 5) or >= 30 (if GCS score is = 9 at time of randomization. - Note: Vasopressors only used to improve cerebral perfusion pressure (e.g., subarachnoid hemorrhage) will not be entered in the calculation of the cardiovascular component of the SOFA score. 6. Receipt of any investigational drug therapy within 30 days prior to randomization. 7. Previous receipt of a mAb within 60 days prior to randomization. 8. Subjects with a CD4 count of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Incidence of nosocomial all-cause pneumonia through 30 days post dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Treatment emergent adverse events (TEAE) and clinical laboratory assessments through 30 days post dose, and treatment emergent serious adverse events (TESAE) and TEAE of special interest (TEAESI) through 90 days, and for a subset of subjects through 180 days post dose. - Incidence of nosocomial all-cause pneumonia or death through 30 days post dose. - Incidence of nosocomial S. aureus pneumonia through 30 days post dose. - Incidence of nosocomial pneumonia caused by S. aureus through 90 days post dose. - Magnitude of healthcare utilization (e.g., duration of mechanical ventilation, duration of ICU stay, duration of hospital stay, number of and days of systemic antibiotic use) through 90 days post dose in all subjects and in a subset of subjects through 180 days post dose. - Suvratoxumab serum concentration and PK parameters through 30 days post dose, and in a subset of subjects through 90 days post dose. - Suvratoxumab ADA response in serum through 30 days post dose, and in a subset of subjects through 90 days post dose. | — |
Countries
Netherlands
Outcome results
None listed