A Phase 1 Study To Assess the Pharmacokinetics of Intravenous Plazomicin in Adult Subjects with Varying Degrees of Renal Function

Plazomicin is an FDA-approved aminoglycoside for the treatment of complicated urinary tract infections. In this open-label study, 24 adults with normal renal function or mild, moderate, or severe renal impairment ( = 6 per group) received a single 7.5-mg/kg of body weight dose of plazomicin as a 30-...

Full description

Saved in:
Bibliographic Details
Published in:Antimicrobial agents and chemotherapy 2018-12, Vol.62 (12)
Main Authors: Komirenko, Allison S, Riddle, Valerie, Gibbons, Jacqueline A, Van Wart, Scott, Seroogy, Julie D
Format: Article
Language:English
Subjects:
Anti-Bacterial Agents
Clinical Therapeutics
Enterobacteriaceae Infections
Renal Insufficiency
Sisomicin
Urinary Tract Infections
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:Plazomicin is an FDA-approved aminoglycoside for the treatment of complicated urinary tract infections. In this open-label study, 24 adults with normal renal function or mild, moderate, or severe renal impairment ( = 6 per group) received a single 7.5-mg/kg of body weight dose of plazomicin as a 30-min intravenous infusion. Total clearance declined with renal impairment, resulting in 1.98-fold and 4.42-fold higher plazomicin exposures, as measured by the area under the concentration-time curve from 0 h to infinity, in subjects with moderate and severe impairment, respectively, than in subjects with normal renal function. (This study has been registered at ClinicalTrials.gov under identifier NCT01462136.).
ISSN:0066-4804
1098-6596
DOI:10.1128/AAC.01128-18