- Conditions
- Staphylococcal Sepsis
- Interventions
- Pagibaximab (formerly BSYX-A110)
- Drug
- Lead sponsor
- Biosynexus Incorporated
- Industry
- Eligibility
- 48 Hours to 120 Hours
- Enrollment
- 88 participants
- Healthy volunteers
- Accepts healthy volunteers
- Timeline
- 2003 – 2004
- U.S. locations
- 1
- States / cities
- Houston, Texas
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- Conditions
- Adenovirus, Anesthesia, Anxiety, Anxiolysis, Autism, Autistic Disorder, Bacterial Meningitis, Bacterial Septicemia, Benzodiazepine, Bipolar Disorder, Bone and Joint Infections, Central Nervous System Infections, Convulsions, Cytomegalovirus Retinitis, Early-onset Schizophrenia Spectrum Disorders, Epilepsy, General Anesthesia, Gynecologic Infections, Herpes Simplex Virus, Infantile Hemangioma, Infection, Inflammation, Inflammatory Conditions, Intra-abdominal Infections, Lower Respiratory Tract Infections, Migraines, Pain, Pneumonia, Schizophrenia, Sedation, Seizures, Skeletal Muscle Spasms, Skin and Skin-structure Infections, Treatment-resistant Schizophrenia, Urinary Tract Infections, Withdrawal, Sepsis, Gram-negative Infection, Bradycardia, Cardiac Arrest, Cardiac Arrhythmia, Staphylococcal Infections, Nosocomial Pneumonia, Neuromuscular Blockade, Methicillin Resistant Staphylococcus Aureus, Endocarditis, Neutropenia, Headache, Fibrinolytic Bleeding, Pulmonary Arterial Hypertension, CMV Retinitis, Hypertension, Chronic Kidney Diseases, Hyperaldosteronism, Hypokalemia, Heart Failure, Hemophilia, Heavy Menstrual Bleeding, Insomnia
- Interventions
- The POPS study is collecting PK data on children prescribed the following drugs of interest per standard of care:
- Drug
- Lead sponsor
- Daniel Benjamin
- Other
- Eligibility
- Up to 21 Years
- Enrollment
- 3,520 participants
- Healthy volunteers
- Healthy volunteers not accepted
- Timeline
- 2011 – 2019
- U.S. locations
- 43
- States / cities
- Anchorage, Alaska • Little Rock, Arkansas • La Jolla, California + 37 more
- Conditions
- Staphylococcal Sepsis
- Interventions
- Placebo, Pagibaximab 50 mg/mL
- Drug
- Lead sponsor
- Biosynexus Incorporated
- Industry
- Eligibility
- Up to 48 Hours
- Enrollment
- 1,579 participants
- Healthy volunteers
- Accepts healthy volunteers
- Timeline
- 2009 – 2011
- U.S. locations
- 1
- States / cities
- Gaithersburg, Maryland
- Conditions
- Neonatal Staphylococcal Sepsis
- Interventions
- Pagibaximab (formerly BSYX-A110)
- Drug
- Lead sponsor
- Biosynexus Incorporated
- Industry
- Eligibility
- 3 Days to 7 Days
- Enrollment
- 53 participants
- Healthy volunteers
- Healthy volunteers not accepted
- Timeline
- 2001 – 2003
- U.S. locations
- 1
- States / cities
- Houston, Texas