Global Trace Module in Safety and Pharmacokinetics of Multiple Dose Metronidazole in Premature Infants

Global Trace Module data
Study Description
The primary objective of this prospective, open-label, multi-center, pharmacokinetic (PK) study was to evaluate the PK and safety of IV metronidazole in premature infants <32 weeks gestational age with suspected serious infection. There were 24 participants enrolled in two age groups based on postnatal age. Each participant received metronidazole and was included in the PK population. Plasma PK was evaluated using a limited sampling scheme. A new dosing strategy based on PMA was developed to account for developmental changes in metronidazole disposition as well as for simplicity in clinical application. The dosing of 7.5 mg/kg Q12 hours in infants PMA <34 weeks and 7.5 mg/kg Q8 hours in infants with a PMA 34-40 weeks, with a loading dose of 15 mg/kg for both age cohorts would achieve therapeutic metronidazole concentrations in the majority (>75%) of infants <90 days of age. In addition, metronidazole was well tolerated in this open-label study. None of the AEs and SAEs reported was related to study drug. Premature infants <32 weeks gestation with suspected serious infection