Prevention of nosocomial pneumonia MedDRA version: 21.1 Level: LLT Classification code 10052596 Term: Nosocomial pneumonia System Organ Class: 100000004862
Conditions
Interventions
Product Code: AR-320
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: SUVRATOXUMAB
Current Sponsor code: AR-320
Other descriptive name: MEDI4893
Concentration unit: mg/ml milligram(s)/m
Sponsors
Aridis Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult (18 [unless otherwise specified by local Country laws] to 65 years of age) or Adolescent (12 to =65 years) no F.1.3.1 Number of subjects for this age range
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 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. APACHE-II score = 25 (if Glasgow Coma Scale [GCS] score is > 5) or = 30 (if GCS score is = 5), or SOFA score = 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 < 200 due to advanced human immunodeficiency virus (HIV) infection. Subjects with a history of HIV infection who have been on highly active antiretroviral therapy and asymptomatic from HIV infection for at least 6 months may be enrolled. 9. History of allergic disease or reactions likely to be exacerbated by any component of the investigational product. 10. Not able to complete long-term follow-up for at least 90 days post dose based on investigator judgment. 11. Pregnant female or nursing mother.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of suvratoxumab on reducing the incidence of nosocomial all-cause pneumonia.;Secondary Objective: 1. To evaluate the safety of a single IV dose of suvratoxumab. 2. To evaluate the effect of suvratoxumab on reducing the incidence of nosocomial all-cause pneumonia or death. 3. To evaluate the effect of suvratoxumab on reducing the incidence of nosocomial S. aureus pneumonia. 4. To evaluate the effect of suvratoxumab on reducing the incidence of long-term nosocomial pneumonia caused by S. aureus. 5. To measure the effect of suvratoxumab on the magnitude of healthcare utilization. 6. To evaluate the serum pharmacokinetics (PK) of suvratoxumab. 7. To evaluate the serum Anti-Drug Antibody (ADA) responses to suvratoxumab.;Primary end point(s): Incidence of nosocomial all-cause pneumonia through 30 days post dose.;Timepoint(s) of evaluation of this end point: Any time through 30 days post dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. TEAEs and clinical laboratory assessments through 30 days post dose, and TESAEs and TEAEs of special interest (TEAESI) through 90 days, and for a subset of subjects through 180 days post dose. 2. Incidence of nosocomial all-cause pneumonia or death through 30 days post dose. 3. Incidence of nosocomial S. aureus pneumonia through 30 days post dose. 4. Incidence of nosocomial pneumonia caused by S. aureus through 90 days post dose. 5. 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. 6. Suvratoxumab serum concentration and PK parameters through 30 days post dose, and in a subset of subjects through 90 days post dose. 7. Suvratoxumab ADA response in serum through 30 days post dose, and in a subset of subjects through 90 days post dose.;Timepoint(s) of evaluation of this end point: 1. Any time through 30 days post dose; any time through 90 days post dose; in a subset of subjects any time through 180 days post dose. 2. Any time through 30 days post dose. 3. Any time through 30 days post dose. 4. Any time through 90 days post dose. 5. Any time through 90 days post dose; in a subset of subjects any time through 180 days post dose. 6. Any time through 30 days post dose; in a subset of subjects any time through 90 days post dose. 7. Any time through 30 days post dose; in a subset of subjects any time through 90 days post dose. | — |
Countries
Belgium, France, Greece, Israel, Netherlands, Portugal, Spain, Switzerland, United States
Contacts
Public ContactClinical Operations
Aridis Pharmaceuticals, Inc.
Outcome results
None listed