Efficacy and safety of a single daily dose of gentamicin in hospitalized Indian children: a quasi-randomized trial.

OBJECTIVES To compare the clinical efficacy, pharmacokinetic profiles and safety of once-daily dosing (ODD) and multiple daily dosing (MDD) of gentamicin in hospitalized Indian children. PATIENTS AND METHODS Four hundred children admitted to our hospital were studied prospectively. The patients were randomized to ODD or MDD groups alternately. The primary outcomes were: (i) a good clinical outcome, as defined; and (ii) occurrence of side effects, if any. Clinical efficacy was determined by comparing the proportion of patients with a favourable response between the two groups, while pharmacokinetic profile was assessed by comparing the peak and trough concentrations of the drug in a subgroup of patients. Safety of the two regimens was compared, besides recording any symptoms due to side effects of the drug, with the help of serum creatinine and brainstem-evoked response audiometry (in a subgroup of the patients). RESULTS We found ODD of gentamicin in hospitalized Indian children to be efficacious and safe. A favourable clinical response was achieved in 167 of the 188 patients (89%) in the ODD group and in 161 of the 212 patients (76%) in the MDD group. Similarly, a higher number of patients in the ODD group showed favourable gentamicin peak concentrations as compared with the MDD group (100% versus 87%). The MDD group showed a higher number of trough concentrations in the undesirable range as compared with the ODD group (17% versus 0%). CONCLUSIONS The study supports extended-interval (single daily) dosing in hospitalized Indian children due to its efficacy and safety with the added advantage of needing fewer injections.