Background: Carbapenems are commonly used in hospitalized infants despite a lack of complete safety data and associations with seizures in older children. We compared the incidence of adverse events in hospitalized infants receiving meropenem versus imipenem/cilastatin.
Methods: We conducted a retrospective cohort study of 5566 infants treated with meropenem or imipenem/cilastatin in neonatal intensive care units managed by the Pediatrix Medical Group between 1997 and 2010. Multivariable conditional logistic regression was performed to evaluate the association between carbapenem therapy and adverse events, controlling for infant factors and severity of illness.
Results: Adverse events were more common with use of meropenem compared with imipenem/cilastatin (62.8/1000 infant days versus 40.7/1000 infant days, P < 0.001). There was no difference in seizures with meropenem versus imipenem/cilastatin (adjusted odds ratio 0.96; 95% confidence interval: 0.68, 1.32). The incidence of death, as well as the combined outcome of death or seizure, was lower with meropenem use—odds ratio 0.68 (0.50, 0.88) and odds ratio 0.77 (0.62, 0.95), respectively.
Conclusion: In this cohort of infants, meropenem was associated with more frequent but less severe adverse events when compared with imipenem/cilastatin.
From the *Duke Clinical Research Institute; †Department of Pediatrics, Duke University, Durham; ‡Department of Biostatistics, University of North Carolina, Chapel Hill, NC; §University of California–San Diego, San Diego, CA; ¶The Children’s Mercy Hospital, Kansas City, MO; ‖Children’s National Medical Center, Washington, DC; and **Pediatrix-Obstetrix Center for Research and Education, Sunrise, FL.
Accepted for publication February 06, 2013.
This work was performed under the Best Pharmaceuticals for Children Act Pediatric Trials Network (Contract No. HHSN275201000003I). This study used Clinical and Translational Science Award biostatistical services through the Division of Pediatric Quantitative Sciences (NIH-5UL-1RR024128-01).
D.K.B. receives support from the United States government for his work in pediatric and neonatal clinical pharmacology (1R01HD057956-02, 1R01FD003519-01, 1U10-HD45962-06, 1K24HD058735-01, and Government Contract HHSN267200700051C) and the nonprofit organization Thrasher Research Foundation for his work in neonatal candidiasis www.thrasherresearch.org; he also receives research support from industry for neonatal and pediatric drug development (www.dcri.duke.edu/research/coi.jsp). M.C.-W. received support from the National Institutes of Health (1K23HD064814); he also receives support from the nonprofit organization Thrasher Research Foundation www.thrasherresearch.org and from industry for neonatal and pediatric drug development (www.dcri.duke.edu/research/coi.jsp). J.v.d.A. receives support from the United States government for his work in pediatric and neonatal clinical pharmacology (5R01HD060543; 5K24DA027992; 5R01HD048689; 5U54HD071601); he also receives research support from the European Union FP7 grants TINN (223614), TINN2 (260908), NEURO - SIS (223060) and GRIP (261060). E.V.C. receives salary support from the United States government (U54 HD071600-01) and research support from Trius, Cerexa Pharmaceuticals, Abbott, and Theravance. P.B.S. receives salary support for research from the National Institutes of Health and the U.S. Department of Health and Human Services (NICHD 1K23HD060040-01, DHHS-1R18AE000028-01, and HHSN267200700051C); he also receives research support from industry for neonatal and pediatric drug development (www.dcri.duke.edu/research/coi.jsp). The authors have no other funding or conflicts of interest to disclose.
Address for correspondence: P. Brian Smith, MD, MPH, MHS, Department of Pediatrics, Duke Clinical Research Institute, Box 17969, Durham, NC 27715. E-mail: firstname.lastname@example.org.
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