Scientific Publications by FDA Staff

Pharmacotherapy 2016 Nov;36(11):1138-44

Antimicrobial monotherapy versus combination therapy for the treatment of complicated intra-abdominal infections.

Petite SE, Bauer SR, Bollinger JE, Ahrens CL, Harinstein LM

STUDY OBJECTIVE: It is unknown if beta-lactam monotherapy is sufficient for complicated intra-abdominal infections or if broader coverage is required, such as with vancomycin. This study sought to determine the clinical outcomes of piperacillin/tazobactam monotherapy compared to combination therapy with vancomycin and piperacillin/tazobactam for complicated intra-abdominal infections among patients within a surgical intensive care unit. DESIGN: Retrospective cohort study. SETTING: Three surgical intensive care units at a tertiary academic medical center. PATIENTS: 417 patients with a secondary peritonitis identified by International Classification of Diseases 9 codes who received either piperacillin/tazobactam monotherapy (228 patients) or piperacillin/tazobactam and vancomycin combination therapy (189 patients). MEASUREMENTS AND MAIN RESULTS: The primary outcome was day 28 clinical cure; secondary outcomes included day 7 clinical cure, length of stay (LOS), and mortality. There were no statistically significant differences between the monotherapy and combination therapy groups with respect to day 28 clinical cure (33.9% vs. 25.5%, p=0.064), day 7 clinical cure (23.6% vs. 17.6%, p=0.14), or 28 day mortality (7% vs. 7.9%, p=0.72). LOS in the ICU was significantly shorter in the monotherapy group (6 days) compared with the combination group (7 days; p=0.04); however, hospital LOS was not significantly different. CONCLUSIONS: No difference was observed in clinical cure rates at day 7 or day 28 between those who received PIP/TAZ monotherapy compared to PIP/TAZ and vancomycin combination therapy.