Health Condition 1: null- Prevention of Staphylococcus aureus Pneumonia in Heavily Colonized, Mechanically Ventilated Subjects
Conditions
Interventions
Intervention1: IV infusions ofsingle IV dose of 3600 mg of ASN100 (comprised of separate infusions each of 1800 mg ASN-1 and 1800 mg ASN-2): IV infusions ofsingle IV dose of 3600 mg of ASN100 (compris
Sponsors
Arsanis Inc
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subject, legally authorized representative, or council of independent physicians (CIP) (if applicable) has provided written informed consent; 2. Subject is >=18 years of age at the time of enrollment; 3. Subject is currently hospitalized and is mechanically ventilated endotracheally (i.e., orotracheal or nasotracheal) and, in the Investigatorâ??s opinion, will require ongoing ventilator support for at least 48 hours; NOTE: Subjects with a tracheostomy at the time of enrollment are not eligible. After enrollment, conversion to tracheostomy is permitted per standard of care. 4. Female subjects must not be pregnant or lactating. Female subjects of childbearing potential must have a documented negative pregnancy test at the Screening Visit. Female subjects may be enrolled on the basis of a negative urine pregnancy test, pending the result of a negative serum pregnancy test prior to randomization; and 5. Female subjects of childbearing potential and non-surgically sterile male subjects who are sexually active must agree to use an approved highly effective form of contraception from the time of informed consent until 165 days post-dose. Approved forms of contraception include hormonal intrauterine devices, hormonal contraceptives (oral birth control pill, depo, patch, or injectable) together with supplementary double barrier methods such as condoms or diaphragms with spermicidal gel or foam. NOTE: The following categories define women who are NOT considered to be of childbearing potential: • Premenopausal female with 1 of the following: o Documented hysterectomy, o Documented bilateral salpingectomy, or o Documented bilateral oophorectomy, or • Postmenopausal female, defined as having amenorrhea for at least 12 months without an alternative medical cause.
Exclusion criteria
Exclusion criteria: 1. Subject has received intravenous (IV) immunoglobulin therapy within 4 months prior to the Screening Visit; 2. Subject has a chest X-ray or thoracic computed tomography (CT) scan that is definitive for a diagnosis of pneumonia; 3. Subject demonstrates both of the following: a. Need for acute changes in ventilator support to enhance oxygenation or to the amount of positive end-expiratory pressure; AND NOTE: Changes made in ventilator support due to day-to-day maintenance other than those changes made to improve oxygenation will not exclude a subject from participation in the study. b. New onset of purulent suctioned respiratory secretions; 4. Subject has a known and documented ETA culture showing heavy colonization with a Gram-negative organism at enrollment or at any time during the Screening period; NOTE: Randomization should not be delayed while waiting for Gram-negative results if heavy colonization with S. aureus has been confirmed. 5. Subject has been diagnosed with neutropenia (absolute neutrophil count 6. Subject has a severe non-pulmonary source of infection which, in the Investigatorâ??s opinion, would interfere with the conduct of the study or jeopardize the subjectâ??s safety; 7. Subject is currently on either continuous veno-venous hemodialysis or extracorporeal membrane oxygenation; 8. Subject has been previously exposed to ASN100 or ASN-1 or ASN-2, individually; 9. Subject has a known hypersensitivity to ASN100 or any of its excipients; 10. Subject has received any investigational product within 30 days prior to the Screening Visit (or 5 half-lives of the investigational product, whichever is longer); 11. Subject has, in the opinion of the Investigator, a high probability of death within 72 hours of enrollment; 12. Subject is, in the opinion of the Investigator, not able or willing to comply with the protocol; 13. Any condition that, in the opinion of the Investigator, would compromise the safety of the subject, the potential activity of the study drug, or the quality of the data; or 14. Subjects with a known history or current (suspected) diagnosis of cytokine release syndrome associated with the administration of peptides, proteins, and/or antibodies.20 NOTE: Subjects with a prior history of sepsis are not excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects in MITT population who develop S. aureus pneumoniaTimepoint: Up to day 22 | — |
Secondary
| Measure | Time frame |
|---|---|
| All cause mortalityTimepoint: 28 days;Duration of mechanical ventilationTimepoint: 21 day;Length of ICU stayTimepoint: 21 days | — |
Countries
Algeria, Czech Republic, France, Georgia, Germany, Hungary, Israel, Poland, Portugal, Romania, Russian Federation, Serbia, South Africa, Spain, Ukraine, United States of America
Contacts
Public ContactTV Thanuja Naidu
Pharm-Olam International (India) Pvt. Ltd
Outcome results
None listed