Randomised trial of oral versus sequential intravenous/oral cephalosporins in children with pyelonephritis.
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.
Neuhaus
Thomas J
TJ
Department of Nephrology, University Children's Hospital Zurich, Steinwiesstrasse 75, 8032, Zurich, Switzerland.
Berger
Christoph
C
Buechner
Katja
K
Parvex
Paloma
P
Bischoff
Gian
G
Goetschel
Philippe
P
Husarik
Daniela
D
Willi
Ulrich
U
Molinari
Luciano
L
Rudin
Christoph
C
Gervaix
Alain
A
Hunziker
Urs
U
Stocker
Sergio
S
Girardin
Eric
E
Nadal
David
D
D000284:Administration, Oral; D000293:Adolescent; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D000077722:Ceftibuten; D002443:Ceftriaxone / Q000008:administration & dosage / Q000627:therapeutic use*; D002511:Cephalosporins / Q000008:administration & dosage / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007223:Infant; D007275:Injections, Intravenous; D008297:Male; D011704:Pyelonephritis / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000473:pathology; D011877:Radionuclide Imaging; D019783:Technetium Tc 99m Dimercaptosuccinic Acid
D000900:Anti-Bacterial Agents; D002511:Cephalosporins; D019783:Technetium Tc 99m Dimercaptosuccinic Acid; D002443:Ceftriaxone; D000077722:Ceftibuten