IRB Proposal

The carbapenem antibiotic meropenem was initially approved by the FDA in 1995 with the dosing regimen of 1 g to be administered every 8 hours. Subsequent studies involving mathematical modeling of pharmacokinetic behavior of this antibiotic proposed a smaller effective dose of 500 mg given every 6 hours, resulting in a lower total daily dose by 1 g. Three previous clinical studies evaluating this revised dosing regimen of meropenem demonstrated similar clinical efficacy. 2, 3 Two of these studies also specifically evaluated costs associated with the alternative dosing regimen, and found a significant cost reduction due to decreased drug acquisition. Based on these prior studies, CUMC phased in alternative dosing scheme in 2008. We would like to perform a retrospective study of the clinical efficacy of meropenem dosing in treating documented infections caused by bacteria containing extended spectrum betalactamases (ESBLs), for which carbapenems, including meropenem, are the treatment of choice. To our knowledge, no prior studies have specifically compared the two dosing regimens of meropenem in treating ESBL infections. By analyzing clinical outcomes data from patients prior to and following this dosing switch, we hope to improve understanding of optimal treatment of ESBL infections and support the current clinical understanding of optimal meropenem dosing.