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

BMJ 2007; 335 doi: (Published 23 August 2007) Cite this as: BMJ 2007;335:386
  1. Giovanni Montini, consultant in paediatric nephrology1,
  2. Antonella Toffolo, consultant in paediatrics2,
  3. Pietro Zucchetta, consultant in nuclear medicine3,
  4. Roberto Dall'Amico, consultant in paediatrics4,
  5. Daniela Gobber, senior lecturer in epidemiology5,
  6. Alessandro Calderan, general practitioner6,
  7. Francesca Maschio, consultant in paediatrics7,
  8. Luigi Pavanello, consultant in paediatrics8,
  9. Pier Paolo Molinari, consultant in paediatrics9,
  10. Dante Scorrano, consultant in paediatrics10,
  11. Sergio Zanchetta, consultant in paediatrics11,
  12. Walburga Cassar, consultant in paediatrics12,
  13. Paolo Brisotto, consultant in paediatrics13,
  14. Andrea Corsini, consultant in paediatrics14,
  15. Stefano Sartori, fellow in paediatrics1,
  16. Liviana Da Dalt, associate professor, paediatric emergency15,
  17. Luisa Murer, consultant in paediatric nephrology1,
  18. Graziella Zacchello, associate professor, paediatric nephrology1
  1. 1Nephrology, Dialysis, and Transplant Unit, Paediatric Department, Azienda Ospedaliera-University of Padua, 35128 Padua, Italy
  2. 2Paediatric Unit, Oderzo Hospital, Italy
  3. 3Nuclear Medicine Department, Azienda Ospedaliera-University of Padua
  4. 4Paediatric Unit, Thiene Hospital, Italy
  5. 5Epidemiology Unit, Azienda Ospedaliera-University of Padua
  6. 6San Donà di Piave, Venice
  7. 7Paediatric Unit, Mestre Hospital, Italy
  8. 8Paediatric Unit, Castelfranco Veneto Hospital, Italy
  9. 9Paediatric Unit, Bologna Hospital, Italy
  10. 10Paediatric Unit, Belluno Hospital, Italy
  11. 11Paediatric Unit, Soave Hospital, Italy
  12. 12Paediatric Unit, Bolzano Hospital, Italy
  13. 13Paediatric Unit, Montebelluna Hospital, Italy
  14. 14Paediatric Unit, Bentivoglio, Italy
  15. 15Emergency Unit, Paediatric Department, Azienda Ospedaliera-University of Padua
  1. Correspondence to: G Montini montini{at}
  • Accepted 17 May 2007


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 9.8×109/l (SD 3.5) v 9.5×109/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.


  • We thank all the members of IRIS (Italian Renal Infection Study Group in children) who made the performance of this study possible. We particularly thank Daniela Gobber (epidemiologist) who died this year. We also thank Jennifer Hartwig, Ian Hewitt, and Federica Fregonese for their help in the preparation of the manuscript, Andrea Ponzoni for statistical analysis, and Roberto Buzzetti for epidemiological advising.

    Participants of the IRIS1 study: I Marella, A Budini (Adria); L Marcazzò, S Bellato (Arzignano); G Audino, G Picco (Bassano); P Colleselli, D Scorrano (Belluno); L Pavanello (Castelfranco); C Crivellaro (Chioggia); G Cattarozzi, M Pitter, A Ballan (Dolo/Mirano); F Rossetti, V Cannella (Este/Monselice); G Svaluto-Moreolo, Caddia (Feltre); F Donzelli, F Maschio (Mestre); P Brisotto, N Crema, S Breseghella (Montebelluna); P Luxardo, A Toffolo (Oderzo); G Zacchello, G Montini, L Murer, C Carasi, B Andreetta, S Comacchio, L Rigon, S Sartori, L Tomasi, R Pertile, D Gobber (epidemiologist), A Ponzoni (statistician) (Padua); A Truini (Piove di Sacco); PG Flora, M Ranieri (San Donà); R Dall'Amico, L Donello (Thiene); G Marcer, S Zanchetta (Soave); M Del Majno, M Gheno (Venice); G Zoppi, P Fortunati (Verona-Borgo Trento); M G Santangelo, O Gianesini (Vicenza); A Corsini (Bentivoglio); PP Molinari (Bologna); A Zucchini (Faenza/Lugo); Venturolli (Forlì); L Serra (Imola); L Casadio (Ravenna); M Principi (Macerata); M Pitschiller, W Cassar (Bolzano); M De Marini, G Crescenzi (Cuneo).

  • Contributors: GM is guarantor; contributed to study design, recruiting the patients, data collection, analysis and interpretation of the data; and wrote the paper. AT contributed to study design, recruiting the patients, data analysis, and final approval of the article. PZ contributed to study design, data analysis, drafting and final approval of the manuscript, and interpreted DMSA scan results. RD'A conceived the study and participated in design and recruitment of patients. DG contributed to design and organisation and was involved in data analysis. AC was responsible to standardising good clinical practice for the study, provided advice on data analysis, and commented on drafts of the paper. FM, LP, PPM, DS, SZ, WC, PB, AC, SS, LDD, LM, GZ contributed to study design, data interpretation, and recruitment of patients.

  • Funding: Region of Veneto (research project 40/01) and association Il Sogno di Stefano (Stephen's Dream).

  • Competing interests: None declared.

  • Ethical approval: Ethics committees of each participating centre approved the study protocol.

  • Accepted 17 May 2007
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