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Randomized, controlled trial comparing once daily and three times daily gentamicin in children with urinary tract infections

Carapetis, Jonathan R., Jaquiery, Anne L., Buttery, Jim P., Starr, Mike, Cranswick, Noel E., Kohn, Sivan, Hogg, Geoffrey G., Woods, Sally and Grimwood, Keith (2001). Randomized, controlled trial comparing once daily and three times daily gentamicin in children with urinary tract infections. Pediatric Infectious Disease Journal,20(3):240-246.

Document type: Journal Article
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Title Randomized, controlled trial comparing once daily and three times daily gentamicin in children with urinary tract infections
Author Carapetis, Jonathan R.
Jaquiery, Anne L.
Buttery, Jim P.
Starr, Mike
Cranswick, Noel E.
Kohn, Sivan
Hogg, Geoffrey G.
Woods, Sally
Grimwood, Keith
Journal Name Pediatric Infectious Disease Journal
Publication Date 2001
Volume Number 20
Issue Number 3
ISSN 0891-3668   (check CDU catalogue open catalogue search in new window)
Start Page 240
End Page 246
Total Pages 7
Place of Publication Hagerstown, MD
Publisher Lippincott
HERDC Category C1 - Journal Article (DEST)
Abstract Objective. To undertake population pharmacokinetic modeling and to determine the safety and efficacy of once daily (OD) gentamicin dosing in children with severe urinary tract infections (UTI).

Methods. An open, randomized, controlled trial comparing OD with three times daily (TD) gentamicin dosing in hospitalized children ages 1 month to 12 years with UTI. Daily doses (milligrams per kg per day) of gentamicin in both groups were 7.5 (<5 years old), 6.0 (5 to 10 years old) and 4.5 (>10 years old).

Results. There were 179 children enrolled (90 OD, 89 TD). Baseline clinical characteristics and pathogens were similar, except that circulatory compromise and renal cortical scintigraphic defects were more common in the OD group. Median gentamicin treatment durations were 3.0 (OD) and 2.7 (TD) days. Mean peak gentamicin concentrations were 17.3 (OD) vs. 6.4 (TD) mg/l; 99% of peak concentrations were >7 mg/l in the OD group whereas 16% of peak concentrations were <5 mg/l in the TD group. Mean trough concentrations were 0.35 (OD) vs. 0.55 (TD) mg/l. In the OD group 4% of trough concentrations were ≥2 mg/l, whereas in the TD group only 0.7% were ≥2 mg/l. Age or prior elevated peak concentrations did not predict high trough concentrations. Population pharmacokinetic modeling of the data fitted a one-compartment model with first order elimination. There were no clinical or bacteriologic failures. The two disease-related complications were confined to the OD group. No nephro- or ototoxicity was identified.

Conclusions. With age-appropriate dosing and measurement of serum trough concentrations before the second dose, OD gentamicin is safe and effective for the treatment of UTI requiring parenteral treatment in children aged 1 month to 12 years.
Keywords Australia
Children
Diseases
drug therapy
Gentamicins
Infection
microbiology
pharmacokinetics
randomized
renal
treatment
 
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Created: Mon, 26 Nov 2007, 15:07:47 CST