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

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

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.

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

Setting 28 paediatric units in north east Italy.

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

Intervention 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°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 9.8x10⁹/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 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.

Trial registration Clinical Trials NCT00161330 [ClinicalTrials.gov] .

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Jonathan C Craig and Elisabeth M Hodson
BMJ 2004 328: 179-180. [Extract] [Full Text] [PDF]

This article has been cited by other articles:

• (2007). Do All Children with Pyelonephritis Require Hospital Admission?. JWatch Emergency Med. 2007: 2-2 [Full text]  
• (2007). Oral vs. Parenteral Antibiotics for Pyelonephritis in Children. JWatch General 2007: 3-3 [Full text]  
• Watson, A. R (2007). Management of urinary tract infection in children. BMJ 335: 356-357 [Full text]  

Rapid Responses:

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