Antibiotics in neonates with gram-positive infections
Clinical trial: Tedizolid pharmacokinetics in pediatric participants with Gram-positive infections
Primary investigator: Dr. Anup Katheria
Research coordinator: Jason Sauberan
About this trial
Drug-resistant bacterial infections are a serious threat to human health, including neonates. Newer antibiotics like tedizolid have been developed to keep pace with and neutralize this threat. In order to determine the correct dose for a neonate, preliminary studies that determine a drug’s pharmacokinetics and safety are commonly done.
This Phase I study will involve giving a single dose of tedizolid to babies in the NICU at Sharp Mary Birch Hospital for Women & Newborns, and then drawing a small sample of their blood at three different times over a one-day time span. Urinalysis and laboratory tests are also performed as a safety evaluation.
This study is being conducted pursuant to requirements of the U.S. Pediatric Research Equity Act and the FDA Safety and Innovation Act.
To learn more about this study, visit ClinicalTrials.gov.