None listed
Conditions
Interventions
AT RANDOMIZATION, SUBJECTS WHO MEET ALL INCLUSION CRITERIA AND NO EXCLUSION CRITERIA WILL BE RANDOMLY ASSIGNED, IN 1:1 RATIO, TO RECEIVE ART-123 IN A DOSE OF 0.06 MG/KG/DAY UP TO A MAXIMUM DOSE OF 6 M
Sponsors
ASAHI KASEI PHARMA AMERICA CORPORATION,
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. SUBJECT MUST BE RECEIVING TREATMENT IN AN ICU, OR IN ACUTE CARE SETTING (E.G., ER, RECOVERY ROOM) WITH DOCUMENTED ORDERS TO TRANSFER TO THE ICU. 2. SUBJECTS WHO HAVE CLINICAL EIDENCE OF BACTERIAL INFECTION AND A KNOWN SITE OF INFECTION (WITH OR WITHOUT CONFIRMATION BY CULTURE) AND ALL OF THE FOLLOWING: A. CURRENTLY RECEIVING TREATMENT WITH ANTIBIOTICS. B. WBC > 12,000/MM³ OR 10 %. C. PLATELET COUNTS IN THE RANGE OF > 30,000/MM³ TO 38°C (IF THE SUBJECT RECEIVED AN ANTIPYRETIC AGENT WITHIN 24 HOURS PRIOR TO SCREENING, THERE MUST BE A DOCUMENTED TEMPERATURE OF GREATER THAN 38°C WITHIN 24 HOURS PRIOR TO ADMINISTRATION OF THE ANTIPYRETIC AGENT IN ORDER TO STILL QUALIFY FOR STUDY PARTICIPATION). AXILLARY TEMPERATURES WILL NOT BE ACCEPTABLE. NOTE: THE PRESENCE OF CONCURRENT FUNGAL OR VIRAL INFECTION IS ALLOWED PROVIDED THAT THE PRIMARY REASON FOR TREATMENT IS BACTERIAL INFECTION. 3. SUBJECTS WITH INFLAMMATORY CHANGES DUE TO SEPSIS DEFINED BY AT LEAST ONE OF THE FOLLOWING: I. CARDIOVASCULAR DYSFUNCTION DEFINED AS RECEIVING VASOPRESSORS TO MAINTAIN MEAN ARTERIAL PRESSURE (MAP) GREATER
Exclusion criteria
Exclusion criteria: 1. SUBJECT OR AUTHORIZED REPRESENTATIVE IS UNABLE TO PROVIDE INFORMED CONSENT (AS APPLICABLE PER LOCAL AND COUNTRY REGULATIONS). 2. SUBJECT IS PREGNANT OR BREASTFEEDING OR INTENDS TO GET PREGNANT WITHIN 28 DAYS OF ENROLLING INTO THE STUDY 3. SUBJECT IS OF CHILDBEARING POTENTIAL AND HAS A POSITIVE PREGNANCY TEST SINCE ADMISSION TO THE HOSPITAL. 4. SUBJECT IS < 18 YEARS OF AGE 5. SUBJECT HAS A KNOWN ALLERGY TO ART-123 OR ANY COMPONENTS OF THE DRUG PRODUCT 6. SUBJECT IS UNIWILLING TO ALLOW TRANSFUSION OF BLOOD OR BLOOD PRODUCTS 7. PRESENCE OF AN ADVANCE DIRECTIVE TO WITHHOLD LIFE-SUSTAINING TREATMENT INCLUDING CARDIOPULMONARY RESUSCITATION (CPR) 8. SUBJECT HAS HAD PREVIOUS TREATMENT WITH ART-123 9. BODY WEIGHT ≥ 175 KG 10. PT PROLONGATION OR THROMBOCYTOPENIA THAT IS NOT DUE TO SEPSIS (E.G. AML OR ALL IN INDUCTION THERAPY, ACUTE LEUKEMIA OF THE M3 TYPE, MYELOABLATIVE THERAPY WITHIN 4 WEEKS PRIOR TO ENROLLEMENT, AIDS WITH PERSISTENT THROMBOCYTOPENIA AND/OR BLEEDING DISORDER, PRE-EXISTING THROMBOCYTOPENIA OR COAGULOPATHY)
Countries
Canada
Contacts
Public ContactLUIS MIGUEL MELENDEZ
PPD Peru S.A.C.
Outcome results
None listed