The approval was based on an open-label, multiple-dose study that evaluated the safety and efficacy of meropenem in the treatment of complicated intra-abdominal infections in children <3 months old. The study examined meropenem use in 200 infants aged <91 days including premature infants across 24 neonatal intensive care units. Efficacy was assessed through the following criteria: death, bacterial cultures, and presumptive clinical cure score. In addition, adverse events and serious adverse events were documented through 3 and 30 days after the last meropenem dose, respectively.
A dosing schedule for the various age groups of infants were created based on how the drug was absorbed and distributed throughout the body. Half of the infants experienced an adverse event, and 17% experienced serious adverse events; no events were probably or definitely related to meropenem. Overall treatment success was 84% among the valuable 192 patients.
Meropenem is a broad-spectrum carbapenem antibiotic already approved for the treatment of complicated intra-abdominal infections and complicated skin infections in adults and older children, as well as for the treatment of bacterial meningitis in children ≥3 months old.
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