title: Antibiotic treatment for pyelonephritis in children: multicentre randomised controlled non-inferiority trial.
abstract: 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.
  
  
  METHODS
  Multicentre, randomised controlled, open labelled, parallel group, non-inferiority trial.
  
  
  METHODS
  28 paediatric units in north east Italy.
  
  
  METHODS
  502 children aged 1 month to <7 years with clinical pyelonephritis.
  
  
  METHODS
  Oral co-amoxiclav (50 mg/kg/day in three doses for 10 days) or parenteral ceftriaxone (50 mg/kg/day in a single parenteral dose) for three days, followed by oral co-amoxiclav (50 mg/kg/day in three divided doses for seven days). Main outcomes measures Primary outcome was the rate of renal scarring. Secondary measures of efficacy were time to defervescence (<37 degrees C), reduction in inflammatory indices, and percentage with sterile urine after 72 hours. An exploratory subgroup analysis was conducted in the children in whom pyelonephritis was confirmed by dimercaptosuccinic acid (DMSA) scintigraphy within 10 days after study entry.
  
  
  RESULTS
  Intention to treat analysis showed no significant differences between oral (n=244) and parenteral (n=258) treatment, both in the primary outcome (scarring scintigraphy at 12 months 27/197 (13.7%) v 36/203 (17.7%), difference in risk -4%, 95% confidence interval -11.1% to 3.1%) and secondary outcomes (time to defervescence 36.9 hours (SD 19.7) v 34.3 hours (SD 20), mean difference 2.6 (-0.9 to 6.0); white cell count 9.8x10(9)/l (SD 3.5) v 9.5x10(9)/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.
  
  
  BACKGROUND
  Clinical Trials NCT00161330 [ClinicalTrials.gov].
authors.affiliation: Nephrology, Dialysis, and Transplant Unit, Paediatric Department, Azienda Ospedaliera-University of Padua, 35128 Padua, Italy. montini@pediatria.unipd.it
authors.forename: Giovanni
authors.initials: G
authors.lastname: Montini
authors.forename: Antonella
authors.initials: A
authors.lastname: Toffolo
authors.forename: Pietro
authors.initials: P
authors.lastname: Zucchetta
authors.forename: Roberto
authors.initials: R
authors.lastname: Dall'Amico
authors.forename: Daniela
authors.initials: D
authors.lastname: Gobber
authors.forename: Alessandro
authors.initials: A
authors.lastname: Calderan
authors.forename: Francesca
authors.initials: F
authors.lastname: Maschio
authors.forename: Luigi
authors.initials: L
authors.lastname: Pavanello
authors.forename: Pier Paolo
authors.initials: PP
authors.lastname: Molinari
authors.forename: Dante
authors.initials: D
authors.lastname: Scorrano
authors.forename: Sergio
authors.initials: S
authors.lastname: Zanchetta
authors.forename: Walburga
authors.initials: W
authors.lastname: Cassar
authors.forename: Paolo
authors.initials: P
authors.lastname: Brisotto
authors.forename: Andrea
authors.initials: A
authors.lastname: Corsini
authors.forename: Stefano
authors.initials: S
authors.lastname: Sartori
authors.forename: Liviana
authors.initials: L
authors.lastname: Da Dalt
authors.forename: Luisa
authors.initials: L
authors.lastname: Murer
authors.forename: Graziella
authors.initials: G
authors.lastname: Zacchello
mesh_terms: D000284:Administration, Oral; D019980:Amoxicillin-Potassium Clavulanate Combination / Q000008:administration & dosage*; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D002443:Ceftriaxone / Q000008:administration & dosage*; D002648:Child; D002675:Child, Preschool; D002921:Cicatrix / Q000000981:diagnostic imaging / Q000209:etiology; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D006801:Humans; D007223:Infant; D007263:Infusions, Parenteral; D007902:Length of Stay; D011704:Pyelonephritis / Q000188:drug therapy*; D011877:Radionuclide Imaging; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D019980:Amoxicillin-Potassium Clavulanate Combination; D002443:Ceftriaxone