A randomised, controlled trial of once daily and multi-dose daily gentamicin in young Kenyan infants

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To test the suitability of a simple once daily (OD) gentamicin regimen for use in young infants where routine therapeutic drug monitoring is not possible.


In an open, randomised, controlled trial, infants with suspected severe sepsis admitted to a Kenyan, rural district hospital received a novel, OD gentamicin regimen or routine multi-dose (MD) regimens.


A total of 297 infants (over 40% ≤7 days) were randomised per protocol; 292 contributed at least some data for analysis of pharmacological endpoints. One hour after the first dose, 5% (7/136) and 28% (35/123) of infants in OD and MD arms respectively had plasma gentamicin concentrations <4 μg/ml (a surrogate of treatment inadequacy). Geometric mean gentamicin concentrations at this time were 9.0 μg/ml (95% CI 8.3 to 9.9) and 4.7 μg/ml (95% CI 4.2 to 5.3) respectively. By the fourth day, pre-dose concentrations ≥2 μg/ml (a surrogate of potential treatment toxicity) were found in 6% (5/89) and 24% (21/86) of infants respectively. Mortality was similar in both groups and clinically insignificant, although potential gentamicin induced renal toxicity was observed in <2% infants.


A “two, four, six, eight” OD gentamicin regime, appropriate for premature infants and those in the first days and weeks of life, seems a suitable, safe prescribing guide in resource poor settings.

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