Abstract
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 (n = 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.).
Keywords:
aminoglycosides; antimicrobial agents; pharmacokinetics; renal impairment.
Copyright © 2018 Komirenko et al.
Publication types
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Clinical Trial, Phase I
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Multicenter Study
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Research Support, Non-U.S. Gov't
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Research Support, U.S. Gov't, Non-P.H.S.
MeSH terms
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Aged
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Anti-Bacterial Agents / blood
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Anti-Bacterial Agents / pharmacokinetics*
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Anti-Bacterial Agents / pharmacology
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Area Under Curve
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Drug Administration Schedule
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Enterobacteriaceae / drug effects
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Enterobacteriaceae / pathogenicity
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Enterobacteriaceae / physiology
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Enterobacteriaceae Infections / blood
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Enterobacteriaceae Infections / drug therapy*
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Enterobacteriaceae Infections / microbiology
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Enterobacteriaceae Infections / physiopathology
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Female
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Humans
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Infusions, Intravenous
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Kidney / drug effects
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Kidney / microbiology
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Kidney / physiopathology
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Kidney Function Tests
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Male
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Middle Aged
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Renal Insufficiency / blood
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Renal Insufficiency / drug therapy*
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Renal Insufficiency / microbiology
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Renal Insufficiency / physiopathology
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Severity of Illness Index
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Sisomicin / analogs & derivatives*
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Sisomicin / blood
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Sisomicin / pharmacokinetics
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Sisomicin / pharmacology
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Urinary Tract Infections / blood
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Urinary Tract Infections / drug therapy*
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Urinary Tract Infections / microbiology
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Urinary Tract Infections / physiopathology
Substances
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Anti-Bacterial Agents
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plazomicin
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Sisomicin
Associated data
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ClinicalTrials.gov/NCT01462136