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Archives of Disease in Childhood logoLink to Archives of Disease in Childhood
. 2004 Jul;89(7):665–669. doi: 10.1136/adc.2003.032284

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

M English 1, S Mohammed 1, A Ross 1, S Ndirangu 1, G Kokwaro 1, F Shann 1, K Marsh 1
PMCID: PMC1719980  PMID: 15210501

Abstract

Aims: 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.

Methods: 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.

Results: 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.

Conclusions: 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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Figure 1.

Figure 1

 Trial profile. *Diagnosed six hours after admission. †Admission creatinine result obtained late, met exclusion criteria.

Selected References

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