Objective: To compare the efficacy of oral antibiotic treatment alone with treatment started parenterally and completed orally in children with a first episode of acute pyelonephritis. Design: Multicentre, randomised controlled, open labelled, parallel group, non-inferiority trial. Setting: 28 paediatric units in north east Italy. Participants: 502 children aged 1 month to 9/l (SD 3.5) v 9.5x109/l (SD 3.1), mean difference 0.3 (-0.3 to 0.9); percentage with sterile urine 185/186 v 203/204, risk difference-0.05% (-1.5% to 1.4%)). Similar results were found in the subgroup of 278 children with confirmed acute pyelonephritis on scintigraphy at study entry. Conclusions: Treatment with oral antibiotics is as effective as parenteral then oral treatment in the management of the first episode of clinical pyelonephritis in children. Trial registration: Clinical Trials NCT00161330.
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