The PTN marks another milestone as the Food and Drug Administration (FDA) has published a summary report of its pediatric study of meropenem in the Federal Register.
Meropenem is a broad-spectrum anti-microbial drug often used to treat intra-abdominal infections in infants. The purpose of the PTN study, which began in the summer of 2008, was to determine the optimal dosing regimen for meropenem in infants younger than 90 days old. Researchers were also interested in determining how safe the drug is for very young infants, especially when compared with imipenem, another broad-spectrum anti-microbial drug closely related to meropenem.
The trial included 200 infants at 24 neonatal intensive care units across the United States. Findings suggested that meropenem as dosed in the study is a safe alternative for young infants with intra-abdominal infections. The FDA recently changed the label for meropenem to reflect these findings, which were published in the Pediatric Infectious Disease Journal.
In accordance with the Public Health Service Act, the FDA is making available the labeling changes for meropenem in the Federal Register.