Table 11.1Evidence profile for clinical outcomes of therapeutic drug monitoring based on plasma gentamicin concentrations and a two-compartment pharmacokinetic model in critically ill babies with suspected sepsis, proven sepsis or pneumonia who received gentamicin by intravenous infusiona

Number of studiesNumber of babiesEffectQuality
Kinetically guided therapeutic monitoringComparison groupRelative (95% confidence interval)Absolute (95% confidence interval)
Cure rates
Cure rate in babies with proven sepsis (those in whom infecting microorganisms were identified)
1
(Martinkova 2010)
13/13
(100%)
-NCNCVery low
Resolution within 5–10 days of clinical signs and laboratory findings suggesting sepsis in babies with suspected sepsis or pneumonia
1
(Martinkova 2010)
68/71
(96%)
-NCNCVery low
Adverse effects kidney dysfunction detected during gentamicin treatment
Gestational age < 34 weeks
1
(Martinkova 2010)
8/27
(30%)
-NCNCVery low
Gestational age 34–38 weeks
1
(Martinkova 2010)
2/22
(9%)
-NCNCVery low
Gestational age > 38 weeks
1
(Martinkova 2010)
13/35
(37%)
-NCNCVery low
Normalisation of serum creatinine concentrations before the end of gentamicin treatment
1
(Martinkova 2010)
13/23
(57%)
-NCNCVery low
Normalisation of serum creatinine concentrations within 1 week of the end of gentamicin treatment
1
(Martinkova 2010)
7/23
(30%)
-NCNCVery low
Adverse effects detected in 2-year follow up after the end of gentamicin treatment
Hearing impairment detected using transient evoked otoacoustic emission recordings during the first or second year of follow-up (impairment was detected only in babies in with grade 3 or 4 hypoxic- ischaemic encephalopathy)
1
(Martinkova 2010)
2/46
(4%)
-NCNCVery low
Nephrocalcinosis detected using ultrasound during the first year of follow-up
1
(Martinkova 2010)
3/68
(4%)
-NCNCVery low
Nephrocalcinosis detected using ultrasound during the second year of follow-up
1
(Martinkova 2010)
0/46
(0%)
-NCNCVery low

NC not calculable

a

The initial gentamicin dosage regimen was 4 mg/kg every 24, 36 or 48 hours depending on gestational age

See the complete GRADE Table J 11.1

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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