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Application of the Hartford Hospital Nomogram for Plazomicin Dosing Interval Selection in Patients with Complicated Urinary Tract Infection.


ABSTRACT: Plazomicin is a new FDA-approved aminoglycoside antibiotic for complicated urinary tract infections (cUTI). In the product labeling, trough-based therapeutic drug management (TDM) is recommended for cUTI patients with renal impairment to prevent elevated trough concentrations associated with serum creatinine increases of ?0.5?mg/dl above baseline. Herein, the utility of the Hartford nomogram to prevent plazomicin trough concentrations exceeding the TDM trough of 3??g/ml and optimize the area under the curve (AUC) was assessed. The AUC reference range was defined as the 5th to 95th percentile AUC observed in the phase 3 cUTI trial (EPIC) (121 to 368 ?g · h/ml). Observed 10-h plazomicin concentrations from patients in EPIC (n?=?281) were plotted on the nomogram to determine an eligible dosing interval (every 24 h [q24h], q36h, q48h). Based on creatinine clearance (CLcr), a 15- or 10-mg/kg of body weight dose was simulated with the nomogram-derived interval. The nomogram recommended an extended interval (q36h and q48h) in 31% of patients. Compared with the 15?mg/kg q24h regimen received by patients with CLcr of ?60 ml/min in EPIC, the nomogram-derived interval reduced the proportion of patients with troughs of ?3 ?g/ml (q36h, 27% versus 0%, P?=?0.021; q48h, 57% versus 0%, P?=?0.002) while significantly increasing the number of patients within the AUC range. Compared with the 8 to 12 mg/kg q24h regimen (received by patients with CLcr of >30 to 59?ml/min in EPIC), the nomogram-derived interval significantly reduced the proportion of troughs of ?3?g/ml in the q48h cohort (72% versus 0%, P?

PROVIDER: S-EPMC6761540 | BioStudies |

REPOSITORIES: biostudies

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