Antibiotic treatment for pyelonephritis in children: multicentre randomised controlled non-inferiority trial

doi:10.1136/bmj.39244.692442.55

BMJ 2007;335:386 (25 August), doi:10.1136/bmj.39244.692442.55 (published 4 July 2007)

Research

Antibiotic treatment for pyelonephritis in children: multicentre randomised controlled non-inferiority trial

Giovanni Montini, consultant in paediatric nephrology¹, Antonella Toffolo, consultant in paediatrics², Pietro Zucchetta, consultant in nuclear medicine³, Roberto Dall'Amico, consultant in paediatrics⁴, Daniela Gobber, senior lecturer in epidemiology⁵, Alessandro Calderan, general practitioner⁶, Francesca Maschio, consultant in paediatrics⁷, Luigi Pavanello, consultant in paediatrics⁸, Pier Paolo Molinari, consultant in paediatrics⁹, Dante Scorrano, consultant in paediatrics¹⁰, Sergio Zanchetta, consultant in paediatrics¹¹, Walburga Cassar, consultant in paediatrics¹², Paolo Brisotto, consultant in paediatrics¹³, Andrea Corsini, consultant in paediatrics¹⁴, Stefano Sartori, fellow in paediatrics¹, Liviana Da Dalt, associate professor, paediatric emergency¹⁵, Luisa Murer, consultant in paediatric nephrology¹, Graziella Zacchello, associate professor, paediatric nephrology¹

¹ Nephrology, Dialysis, and Transplant Unit, Paediatric Department, Azienda Ospedaliera-University of Padua, 35128 Padua, Italy, ² Paediatric Unit, Oderzo Hospital, Italy, ³ Nuclear Medicine Department, Azienda Ospedaliera-University of Padua, ⁴ Paediatric Unit, Thiene Hospital, Italy, ⁵ Epidemiology Unit, Azienda Ospedaliera-University of Padua, ⁶ San Donà di Piave, Venice, ⁷ Paediatric Unit, Mestre Hospital, Italy, ⁸ Paediatric Unit, Castelfranco Veneto Hospital, Italy , ⁹ Paediatric Unit, Bologna Hospital, Italy , ¹⁰ Paediatric Unit, Belluno Hospital, Italy , ¹¹ Paediatric Unit, Soave Hospital, Italy , ¹² Paediatric Unit, Bolzano Hospital, Italy , ¹³ Paediatric Unit, Montebelluna Hospital, Italy , ¹⁴ Paediatric Unit, Bentivoglio, Italy, ¹⁵ Emergency Unit, Paediatric Department, Azienda Ospedaliera-University of Padua

Correspondence to: G Montini montini{at}pediatria.unipd.it

Objective To compare the efficacy of oral antibiotic treatmentalone with treatment started parenterally and completed orallyin children with a first episode of acute pyelonephritis.

Design Multicentre, randomised controlled, open labelled, parallelgroup, non-inferiority trial.

Setting 28 paediatric units in north east Italy.

Participants 502 children aged 1 month to <7 years with clinicalpyelonephritis.

Intervention Oral co-amoxiclav (50 mg/kg/day in three dosesfor 10 days) or parenteral ceftriaxone (50 mg/kg/day in a singleparenteral 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 renalscarring. Secondary measures of efficacy were time to defervescence(<37°C), reduction in inflammatory indices, and percentagewith sterile urine after 72 hours. An exploratory subgroup analysiswas conducted in the children in whom pyelonephritis was confirmedby dimercaptosuccinic acid (DMSA) scintigraphy within 10 daysafter study entry.

Results Intention to treat analysis showed no significant differencesbetween oral (n=244) and parenteral (n=258) treatment, bothin 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 (SD20), mean difference 2.6 (–0.9 to 6.0); white cell count9.8x10⁹/l (SD 3.5) v 9.5x10⁹/l (SD 3.1), mean difference 0.3(–0.3 to 0.9); percentage with sterile urine 185/186 v203/204, risk difference –0.05% (–1.5% to 1.4%)).Similar results were found in the subgroup of 278 children withconfirmed acute pyelonephritis on scintigraphy at study entry.

Conclusions Treatment with oral antibiotics is as effectiveas parenteral then oral treatment in the management of the firstepisode of clinical pyelonephritis in children.

Trial registration Clinical Trials NCT00161330 [ClinicalTrials.gov] .

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Rapid Responses:

Read all Rapid Responses

Parenteral or oral antibiotics in childhood pyelonephritis: Does the debate still continue: Ahmet Karadag, et al.
bmj.com, 18 Jul 2007 [Full text]
Response to Montini Article: Alejandro Hoberman, et al.
bmj.com, 12 Oct 2007 [Full text]
Response to Montini article - Is this study valid?: V Ganesan
bmj.com, 26 Nov 2007 [Full text]
Re: Response to Montini Article: Giovanni Montini, et al.
bmj.com, 9 Dec 2007 [Full text]
Re: Response to Montini article - Is this study valid?: Giovanni Montini
bmj.com, 9 Dec 2007 [Full text]