This study evaluated the safety and pharmacokinetics (PK) of intravenous metronidazole in premature infants with suspected serious infection. Twenty-four participants, less than 32 weeks gestational age with suspected serious infection, participated in the study for up to 15 days at three centers. The Pediatric Trials Network generated PK data to guide dosing of metronidazole in premature infants using a simplified dosing regimen based on postmenstrual age.

Gregory Kearns, PharmD, PhD, of Children's Mercy Hospital Kansas City, discusses the PTN metronidazole study: clinical pharmacology in action.

Brian Smith, MD, MPH, of the Duke Clinical Research Institute, discusses the metronidazole in premature infants study.

Summary

Metronidazole is approved by the U.S. Food and Drug Administration for the treatment of adults with infections caused by anaerobic bacteria. Children and premature infants may be affected by these bacteria too; therefore, doctors frequently give metronidazole to infants who are suspected of having an infection caused by anaerobic bacteria. However, the appropriate dose of metronidazole in premature infants is not well-known.

We enrolled 24 babies <32 weeks gestational age with suspected serious infection and administered metronidazole for up to five days, measuring the levels of metronidazole in each baby. With this information, we were able to determine the appropriate dose of metronidazole in premature infants. Because metronidazole likely behaves differently in premature infants than it does in term infants, older children, and adults, this study meets a public health need for better evidence in the treatment of this vulnerable group.

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