Randomized trial of oral versus sequential IV/oral antibiotic for acute pyelonephritis in children

Pediatrics. 2012 Feb;129(2):e269-75. doi: 10.1542/peds.2011-0814. Epub 2012 Jan 30.


Objective: To confirm whether oral antibiotic treatment is as efficacious as sequential intravenous/oral antibiotic treatment in the prevention of renal scarring in children with acute pyelonephritis and scintigraphy-documented acute lesions.

Methods: In a prospective multicenter trial, children aged 1 to 36 months with their first case of acute pyelonephritis, a serum procalcitonin concentration ≥0.5 ng/mL, no known uropathy, and a normal ultrasound exam were randomized into 2 treatment groups. They received either oral cefixime for 10 days or intravenous ceftriaxone for 4 days followed by oral cefixime for 6 days. Patients with acute renal lesions detected on early dimercaptosuccinic acid scintigraphy underwent a follow-up scintigraphy 6 to 8 months later.

Results: The study included 171 infants and children. There were no significant differences between the 2 groups in any clinical characteristic. Initial scintigraphy results were abnormal for 119 children. Ninety-six children were measured for renal scarring at the follow-up scintigraphy (per protocol analysis population). The incidence of renal scarring was 30.8% in the oral treatment group and 27.3% for children who received the sequential treatment.

Conclusions: Although this trial does not statistically demonstrate the noninferiority of oral treatment compared with the sequential treatment, our study confirmed the results of previously published reports and therefore supports the use of an oral antibiotic treatment of primary episodes of acute pyelonephritis in infants and young children.

Trial registration: ClinicalTrials.gov NCT00136656.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acute Disease
  • Administration, Oral
  • Anti-Bacterial Agents / administration & dosage*
  • Anti-Bacterial Agents / adverse effects
  • Calcitonin / blood
  • Calcitonin Gene-Related Peptide
  • Cefixime / administration & dosage*
  • Cefixime / adverse effects
  • Ceftriaxone / administration & dosage*
  • Ceftriaxone / adverse effects
  • Child, Preschool
  • Drug Administration Schedule
  • Escherichia coli Infections / blood
  • Escherichia coli Infections / diagnostic imaging
  • Escherichia coli Infections / drug therapy*
  • Female
  • Humans
  • Infant
  • Infusions, Intravenous
  • Male
  • Prospective Studies
  • Protein Precursors / blood
  • Pyelonephritis / blood
  • Pyelonephritis / diagnostic imaging
  • Pyelonephritis / drug therapy*
  • Radionuclide Imaging


  • Anti-Bacterial Agents
  • CALCA protein, human
  • Protein Precursors
  • Ceftriaxone
  • Calcitonin
  • Cefixime
  • Calcitonin Gene-Related Peptide

Associated data

  • ClinicalTrials.gov/NCT00136656