Simplified Dosing of Gentamicin for Treatment of Sepsis in Bangladeshi Neonates|
Hossain, M. Monir; Chowdhury, Nazma A.; Shirin, Mahfuza; Saha, Samir K.; Miller-Bell, Mary; Edwards, David; Aranda, Jacob; Coffey, Patricia & Darmstadt, Gary L.
Extended-interval dosing of gentamicin has several advantages over conventional multiple-daily dosing
for the treatment of sepsis. The study was conducted to evaluate the pharmacokinetics of gentamicin for
the treatment of neonatal sepsis in predetermined doses at 24- or 48-hour intervals, according to weight
category, and to develop a simplified protocol for use in peripheral healthcare settings in developing countries.
This prospective observational study was conducted among 59 neonates admitted to the Special Care
Nursery at Dhaka Shishu Hospital, Bangladesh, with suspected sepsis and treated with antibiotics, including
gentamicin. Intravenous dosing of gentamicin according to weight category was: 10 mg every 48 hours
if the infant weighed <2,000 g (n=23), 10 mg every 24 hours if the infant weighed 2,000-2,249 g (n=12), or
13.5 mg every 24 hours if the infant weighed 2,500-3,000 g (n=24). Peak and trough concentrations of gentamicin
and the presence of signs of nephrotoxicity and ototoxicity were determined. The mean±standard
deviation peak concentration of gentamicin was 12.3±3.7 μg/mL in infants weighing <2,000 g, 9.6±3.1
μg/mL in infants 2,000-2,249 g, and 10.0±3.4 μg/mL in infants 2,500-3,000 g. Initial peak concentration
of gentamicin was >12 μg/mL in 28.8% and initial trough concentration was >2 μg/mL in 6.8% of the
subjects. No signs of nephrotoxicity or ototoxicity were detected. Favourable pharmacokinetic parameters
found with the simplified dosing regimen suggest that it is safe for the treatment of neonatal sepsis.
Aminoglycoside; Antibiotics; Gentamicin; Infection; Newborns; Observational studies; Pharmacokinetics; Prospective studies; Sepsis; Bangladesh