Efficacy and safety of amikacin in systemic infections when given as a single daily dose or in two divided doses. Scandinavian Amikacin Once Daily Study Group.

Two hundred and twenty patients with serious infections verified or suspected to be of Gram-negative aetiology were treated in an open randomized comparative multicentre trial with amikacin 15 mg/kg/day given either as a single dose or in two divided doses at 12-h intervals. Amikacin was administered as a short-term iv infusion. When additional therapy was considered necessary piperacillin or ampicillin was recommended. The trial continues and an interim report on data from the 12 participating Scandinavian hospitals is presented. One hundred and forty-four patients have been evaluated for efficacy and 213 patients for safety. There were no significant differences between the two dosage regimens regarding efficacy and safety. A satisfactory clinical response was recorded in 129 (90%) of the evaluable patients. One serious adverse reaction was seen in a patient in the once-daily group. This was ototoxicity which was superimposed on a long standing hearing defect possibly caused by previous streptomycin therapy.

RCT Entities:   Population Interventions Outcomes