Antibiotic treatment for pyelonephritis in children: multicentre randomised controlled non-inferiority trial.
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].
Montini
Giovanni
G
Nephrology, Dialysis, and Transplant Unit, Paediatric Department, Azienda Ospedaliera-University of Padua, 35128 Padua, Italy. montini@pediatria.unipd.it
Toffolo
Antonella
A
Zucchetta
Pietro
P
Dall'Amico
Roberto
R
Gobber
Daniela
D
Calderan
Alessandro
A
Maschio
Francesca
F
Pavanello
Luigi
L
Molinari
Pier Paolo
PP
Scorrano
Dante
D
Zanchetta
Sergio
S
Cassar
Walburga
W
Brisotto
Paolo
P
Corsini
Andrea
A
Sartori
Stefano
S
Da Dalt
Liviana
L
Murer
Luisa
L
Zacchello
Graziella
G
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
D000900:Anti-Bacterial Agents; D019980:Amoxicillin-Potassium Clavulanate Combination; D002443:Ceftriaxone