Randomised trial of oral versus sequential intravenous/oral cephalosporins in children with pyelonephritis

Eur J Pediatr. 2008 Sep;167(9):1037-47. doi: 10.1007/s00431-007-0638-1. Epub 2007 Dec 12.

Abstract

The hypothesis was tested that oral antibiotic treatment in children with acute pyelonephritis and scintigraphy-documented lesions is equally as efficacious as sequential intravenous/oral therapy with respect to the incidence of renal scarring. A randomised multi-centre trial was conducted in 365 children aged 6 months to 16 years with bacterial growth in cultures from urine collected by catheter. The children were assigned to receive either oral ceftibuten (9 mg/kg once daily) for 14 days or intravenous ceftriaxone (50 mg/kg once daily) for 3 days followed by oral ceftibuten for 11 days. Only patients with lesions detected on acute-phase dimercaptosuccinic acid (DMSA) scintigraphy underwent follow-up scintigraphy. Efficacy was evaluated by the rate of renal scarring after 6 months on follow-up scintigraphy. Of 219 children with lesions on acute-phase scintigraphy, 152 completed the study; 80 (72 females, median age 2.2 years) were given ceftibuten and 72 (62 females, median age 1.6 years) were given ceftriaxone/ceftibuten. Patients in the intravenous/oral group had significantly higher C-reactive protein (CRP) concentrations at baseline and larger lesion(s) on acute-phase scintigraphy. Follow-up scintigraphy showed renal scarring in 21/80 children treated with ceftibuten and 33/72 with ceftriaxone/ceftibuten (p = 0.01). However, after adjustment for the confounding variables (CRP and size of acute-phase lesion), no significant difference was observed for renal scarring between the two groups (p = 0.2). Renal scarring correlated with the extent of the acute-phase lesion (r = 0.60, p < 0.0001) and the grade of vesico-ureteric reflux (r = 0.31, p = 0.03), and was more frequent in refluxing renal units (p = 0.04). The majority of patients, i.e. 44 in the oral group and 47 in the intravenous/oral group, were managed as out-patients. Side effects were not observed. From this study, we can conclude that once-daily oral ceftibuten for 14 days yielded comparable results to sequential ceftriaxone/ceftibuten treatment in children aged 6 months to 16 years with DMSA-documented acute pyelonephritis and it allowed out-patient management in the majority of these children.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Administration, Oral
  • Adolescent
  • Anti-Bacterial Agents / administration & dosage
  • Anti-Bacterial Agents / therapeutic use*
  • Ceftibuten
  • Ceftriaxone / administration & dosage
  • Ceftriaxone / therapeutic use*
  • Cephalosporins / administration & dosage
  • Cephalosporins / therapeutic use*
  • Child
  • Child, Preschool
  • Drug Administration Schedule
  • Female
  • Humans
  • Infant
  • Injections, Intravenous
  • Male
  • Pyelonephritis / diagnostic imaging
  • Pyelonephritis / drug therapy*
  • Pyelonephritis / pathology
  • Radionuclide Imaging
  • Technetium Tc 99m Dimercaptosuccinic Acid

Substances

  • Anti-Bacterial Agents
  • Cephalosporins
  • Technetium Tc 99m Dimercaptosuccinic Acid
  • Ceftriaxone
  • Ceftibuten