Table 11.4Evidence profile for therapeutic drug monitoring based on serum gentamicin concentrations and a simplified method for individualising dosage regimens (not dependent on individualised pharmacokinetic modelling) in babies who received gentamicin by intravenous injection in a neonatal intensive care unita

Number of studiesNumber of babiesEffectQuality
Simplified therapeutic monitoringComparison groupRelative (95% confidence interval)Absolute (95% confidence interval)
Bias and precision of predicted steady-state peak and trough serum gentamicin concentrations
Bias for trough concentration (difference between observed and predicted concentrations) in babies who received serum gentamicin before and at 1 hour after the second dose of gentamicin followed by adjustment to the dosage regimen (mg/l)
1
(Herngren 1986)
15b-NCNCVery low
Precision for trough concentration (absolute difference between observed and predicted trough concentrations)1 mg/l in babies who received serum gentamicin before and at 1 hour after the second dose of gentamicin followed by adjustment to the dosage regimen
1
(Herngren 1986)
15
(73%)c
-NCNCVery low
Correlations between observed and predicted steady-state peak and trough concentrations
Correlation between observed and predicted peak and trough concentrations in babies who received serum gentamicin before and at 1 hour after the second dose of gentamicin followed by adjustment to the dosage regimen (pooled data for peak and trough concentrations)
1
(Herngren 1986)
15d-NCNCVery low
Correlation between observed and predicted peak concentrations in babies who received serum gentamicin before and at 1 hour after the second dose of gentamicin followed by adjustment to the dosage regimen
1
(Herngren 1986)
15e-NCNCVery low
Correlation between observed and predicted trough concentrations in babies who received serum gentamicin before and at 1 hour after the second dose of gentamicin followed by adjustment to the dosage regimen
1
(Herngren 1986)
15f-NCNCVery low
Correlation between observed and predicted peak and trough concentrations in babies who received serum gentamicin before and at 1, 3 and 5 hours after the second or third dose of gentamicin with no adjustment to the dosage regimen (pooled data for peak and trough concentrations)
1
(Herngren 1986)
20g-NCNCVery low
Correlation between observed and predicted peak concentrations in babies who received serum gentamicin before and at 1, 3 and 5 hours after the second or third dose of gentamicin with no adjustment to the dosage regimen
1
(Herngren 1986)
20h-NCNCVery low
Correlation between observed and predicted trough concentrations in babies who received serum gentamicin before and at 1, 3 and 5 hours after the second or third dose of gentamicin with no adjustment to the dosage regimen
1
(Herngren 1986)
20i-NCNCVery low

NC not calculable

a

The initial gentamicin dosage regimen was 2.5 mg/kg every 12 hours in babies with birthweight < 2.5 kg and 3.75 mg/kg every 12 hours in babies with birthweight > 2.5 kg

b

Difference between observed and predicted trough serum gentamicin concentrations 0.7 (95% confidence interval not reported)

c

Number of babies with precision for trough concentrations ≤ 1 mg/l not reported

d

Correlation coefficient r = 0.92, P not reported

e

Correlation coefficient r = 0.63, P not reported

f

Correlation coefficient r = 0.21, P not reported

g

Correlation coefficient r = 0.90, P not reported

h

Correlation coefficient r not reported, P < 0.005

i

Correlation coefficient r not reported, P < 0.005

See the complete GRADE Table J 11.4

From: 11, Therapeutic drug monitoring for gentamicin

Cover of Antibiotics for Early-Onset Neonatal Infection
Antibiotics for Early-Onset Neonatal Infection: Antibiotics for the Prevention and Treatment of Early-Onset Neonatal Infection.
NICE Clinical Guidelines, No. 149.
National Collaborating Centre for Women's and Children's Health (UK).
London: RCOG Press; 2012 Aug.
Copyright © 2012, National Collaborating Centre for Women’s and Children’s Health.

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