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Publication Type : Journal Article
Publisher : J Antimicrob Chemother
Source : J Antimicrob Chemother. 2009 Nov;64(5):1096-101
Url : https://pubmed.ncbi.nlm.nih.gov/19759043/
Campus : Faridabad
Year : 2009
Abstract : 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.
Cite this Research Publication : Tiwari S, Rehan HS, Chandra J, Mathur NN, Singh V.J. Efficacy and safety of a single daily dose of gentamicin in hospitalized Indian children: a quasi-randomized trial.J Antimicrob Chemother. 2009 Nov;64(5):1096-101