Safety and Pharmacokinetics of Exebacase in an Infant with Disseminated Staphylococcus aureus Infection.
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2021-12-11
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Abstract
Exebacase, an anti-staphylococcal lysin produced from a bacteriophage-encoded gene, is a promising adjunctive therapy for severe methicillin-resistant Staphylococcus aureus infections. We describe the first infant to receive exebacase, dosing, and pharmacokinetics (PK). Exebacase may be safe and efficacious in children; however, further clinical trials are needed to optimize dosing.
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Moorthy, Ganga S, Rachel G Greenberg, Chi D Hornik, Cara Cassino, Parviz Ghahramani, Karan R Kumar, Vance G Fowler, Michael Cohen-Wolkowiez, et al. (2021). Safety and Pharmacokinetics of Exebacase in an Infant with Disseminated Staphylococcus aureus Infection. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America. 10.1093/cid/ciab1015 Retrieved from https://hdl.handle.net/10161/24321.
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Scholars@Duke
Ganga Moorthy
Rachel Gottron Greenberg
Rachel G. Greenberg, MD, MB, MHS is a neonatologist and Associate Professor of Pediatrics at Duke University Medical Center and Duke Clinical Research Institute. Dr. Greenberg’s research focuses on improving safety and efficacy of drugs in infants and children, particularly through her efforts as co-Investigator and Steering Committee Chair for the NICHD-funded Pediatric Trials Network. She is also alternate PI of the North Carolina clinical Center for the Neonatal Research Network and PI of the NICHD-funded HEAL KIDS Pain Resource and Data Center. In addition, she has been principal investigator of multiple trials funded by the U.S. Food and Drug Administration, Centers for Disease Control, and National Institutes of Health.
Chi Hornik
Chi Hornik is the Director of Heart Center Research and the Director of Critical Care Medicine Research in the Department of Pediatrics. She is an Associate Professor in the Duke School of Medicine and a member of the Duke Clinical Research Institute (DCRI). She serves as Principal Investigator (PI) of Duke as a site for numerous studies and as clinical coordinating center PI of multi-center trials through the DCRI. As a clinical specialist in neonatal and pediatric critical care, she is dedicated to advancing drug and device development. She ensures that the research encompasses patients who are representative of the disease or condition being studied. Her commitment is to advance health outcomes for all children, striving for equity in clinical research.
Karan Ravindra Kumar
I am an Assistant Professor of Pediatrics and a Pediatric Critical Care Physician at Duke University School of Medicine, and I am also affiliated with the Duke Clinical Research Institute (DCRI). My research focuses on advancing pediatric healthcare through the integration of biostatistics, clinical research informatics, and data science. I have significant experience managing large datasets, including the Pediatrix Medical Group Clinical Data Warehouse and the NICHD-funded Pediatric Trials Network, which have provided vital insights into disease patterns and pediatric drug labeling. I contribute analytical support to various pediatric research initiatives. My efforts extend to exploring automation of data integration in clinical trials, enhancing research infrastructure, and leading critical trials and registries to improve pediatric health outcomes. I am enthusiastic about applying my expertise in biostatistics, database management, and predictive analytics to future projects.
Vance Garrison Fowler
Determinants of Outcome in Patients with Staphylococcus aureus Bacteremia
Antibacterial Resistance
Pathogenesis of Bacterial Infections
Tropical medicine/International Health
Michael Cohen-Wolkowiez
Pediatric and adult clinical pharmacology and clinical trials.
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