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Pyrogenic Reactions Associated With Single Daily Dosing of Intravenous Gentamicin

Published online by Cambridge University Press:  02 January 2015

Udo Buchholz
Affiliation:
Epidemic Intelligence Service, Epidemiology Program Office, Centers for Disease Control and Prevention, Atlanta, Georgia Acute Communicable Disease Control, Los Angeles County Department of Health Services, Los Angeles, California
Chesley Richards*
Affiliation:
Epidemic Intelligence Service, Epidemiology Program Office, Centers for Disease Control and Prevention, Atlanta, Georgia Hospital Infections Program, Centers for Disease Control and Prevention, Atlanta, Georgia
Rekha Murthy
Affiliation:
Cedars-Sinai Medical Center, Los Angeles, California
Matthew Arduino
Affiliation:
Hospital Infections Program, Centers for Disease Control and Prevention, Atlanta, Georgia
Doreen Pon
Affiliation:
Cedars-Sinai Medical Center, Los Angeles, California
Wayne Schwartz
Affiliation:
Cedars-Sinai Medical Center, Los Angeles, California
Elsie Fontanilla
Affiliation:
Cedars-Sinai Medical Center, Los Angeles, California
Clare Pegues
Affiliation:
Cedars-Sinai Medical Center, Los Angeles, California
Noemy Boghossian
Affiliation:
Cedars-Sinai Medical Center, Los Angeles, California
Carol Peterson
Affiliation:
Acute Communicable Disease Control, Los Angeles County Department of Health Services, Los Angeles, California
Jacob Kool
Affiliation:
Acute Communicable Disease Control, Los Angeles County Department of Health Services, Los Angeles, California
Laurene Mascola
Affiliation:
Acute Communicable Disease Control, Los Angeles County Department of Health Services, Los Angeles, California
William R. Jarvis
Affiliation:
Hospital Infections Program, Centers for Disease Control and Prevention, Atlanta, Georgia
*
Centers for Disease Control and Prevention, Hospital Infections Program, Mailstop A-07, 1600 Clifton Rd, Atlanta, GA 30333

Abstract

Objective:

To identify risk factors associated with an unexpected outbreak of pyrogenic reactions (PR) following intravenous gentamicin.

Design:

We conducted two cohort studies. PRs were defined as chills, rigors, or shaking within 3 hours after initiating the gentamicin infusion during the preepidemic (December 1, 1997-January 15,1998) or epidemic (May 1-June 15,1998) periods. We tested gentamicin vials for endotoxin using the limulus amebocyte lysate assay.

Setting:

Inpatient services of a large community hospital in Los Angeles, California.

Results:

During the epidemic period, 22 (15%) of 152 patients developed documented PRs following intravenous gentamicin. PRs were more likely among patients receiving single daily dosing (SDD) than multiple daily dosing gentamicin (20/73 [27%] vs 2/79 [3%]; relative risk, 10.8; 95% confidence interval, 2.644.7). Laboratory analysis of gentamicin vials found endotoxin levels that were higher among Fujisawa-brand gentamicin (implicated brand) than gentamicin used after the outbreak terminated (non-implicated brand). Although endotoxin levels in the vials did not exceed US Pharmacopeia limits (1.7 endotoxin units/mg gentamicin), the use of SDD gentamicin may place patients at greater risk of receiving doses of endotoxin above the threshold for PRs in humans.

Conclusions:

Reassessment of the acceptable amounts of endotoxin in gentamicin and other parenteral products should be considered when dosing intervals used in clinical practice change.

Type
Original Articles
Copyright
Copyright © The Society for Healthcare Epidemiology of America 2000

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