Evaluation of the Effectiveness of Antibiotic Prophylaxis in Children With a Previous Urinary Tract Infection
NCT ID: NCT00156546
Last Updated: 2005-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
660 participants
INTERVENTIONAL
2000-05-31
2006-07-31
Brief Summary
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Detailed Description
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Upper urinary tract infections (UTI) are common in children, especially when functional and anatomical abnormalities of the urinary tract co-exist, such as vesico-ureteral reflux (VUR), urinary tract obstruction uropathy and bladder dysfunction. They are associated with the risk of long-term complications, including permanent renal damage (renal scarring), which occurs in 15% of cases. The objective of the diagnosis and medical treatment of UTI in children is the prevention of such complications. Medical treatment includes long-term antimicrobial prophylaxis to be continued for periods ranging from 6 months to 2 years. Recent studies have revealed the emergence of therapy-induced resistance. A review of the literature has highlighted the lack of properly designed, large clinical trials, demonstrating the efficacy of long-term low-dose antimicrobial prophylaxis in terms of reduction in UTI recurrence.
Methods and design
The study is a controlled, randomised, open-label, 3-armed, parallel-group clinical trial comparing no prophylaxis (group 1) with prophylaxis with co-trimoxazole 15 mg/kg daily (group 2) and with amoxicillin + clavulanic acid 15 mg/kg daily (group 3) for 12 months.
Assuming that the incidence of recurrences is 20%, defining efficacy as an incidence of 10% per group and setting error = 0.05 and power = 90%, 220 patients per group (i.e. a total of 660 patients) are required The study population will consist of children aged between 2 months and 6 years, with normal renal function (creatinine clearance 70 ml/min/1.73m2) and a first episode of documented UTI, who presents at least one of the following: an acute pyelonephritic lesion at the DMSA scan and/or a VUR at the baseline micturating cystography.
Patients will be followed-up for 12 months. Urinalysis and urine cultures will be performed every month and clinical examinations after 6 and 12 months; both will be performed whenever UTI is suspected. Sonography, Doppler sonography (optional) and DMSA scintigraphy will be performed at baseline and at the end of the study.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Interventions
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antibiotic to reduce the recurrence of infection
Eligibility Criteria
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Inclusion Criteria
* Creatinine clearance (calculated according to Schwartz) 70 ml/min/1.73 m2 (for children in their first year of life, serum creatinine levels within normal range for age and sex)
* First documented upper UTI (diagnostic criteria in Table 1)
* Imaging Diagnostic work-up completed (Table 2) with at least the presence of an acute lesion at the DMSA scan and or a primary non severe reflux ( 1st or 3rd degree)
* Informed consent of parents
Exclusion Criteria
* Patients with urinary tract disorders, such as vesico-ureteral reflux due to complex malformations of the urinary tract, obstruction of the posterior urethra, ureterocele or single kidney, neurogenic bladder
* Patients with reflux 4th degree
* Patients with pyelonephritis that developed during prophylaxis instituted because of prenatal diagnosis of urinary tract dilatation Hypersensitivity to one of the two selected antimicrobial agents
2 Months
6 Years
ALL
No
Sponsors
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Regione Veneto
OTHER
IL Sogno di Stefano
OTHER
University of Padova
OTHER
Principal Investigators
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Graziella Zacchello, Professor
Role: STUDY_CHAIR
Departement of Pediatrics, University of Padova
Antonella Toffolo, Dr
Role: PRINCIPAL_INVESTIGATOR
Pediatric Unit Ospedale di Oderzo (TV) Italy
Alessandro Calderan, Dr
Role: PRINCIPAL_INVESTIGATOR
Giovanni Montini, Dr
Role: PRINCIPAL_INVESTIGATOR
Nephrology, Dialysis and Transplant Unit, Pediatric Departement, Azienda Ospedaliera-Università, Padova
Locations
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Pediatric Unit, Ospedale di Belluno
Belluno, Belluno, Italy
Pediatric Unit, Ospedale di Bentivoglio
Bentivoglio, Bologna, Italy
- Pediatric Department, Ospedale di Bolzano
Bolzano, Bolzano, Italy
Pediatric Unit, Ospedale di Cuneo
Cuneo, Cuneo, Italy
Pediatric Unit, Ospedale di Este - Monselice
Monselice, Padova, Italy
Nephrology, Dialysis and transplant Unit Pediatric Depatment,
Padua, Padova, Italy
Pediatric Unit, Ospedale di Piove di Sacco e Chioggia
Piove di Sacco, Padova, Italy
Pediatric Unit, Ospedale di Ravenna
Ravenna, Ravenna, Italy
Pediatric Unit, Ospedale di Castelfranco
Castelfranco Veneto, Treviso, Italy
Pediatric Unit, Ospedale di Motta di Livenza
Motta Di Livenza Oderzo, Treviso, Italy
Pediatric Unit, Ospedale di Dolo
Dolo, Venezia, Italy
Pediatric Unit, Ospedale di Soave
Soave, Verona, Italy
Pediatric Unit, Ospedale di Schio/Thiene
Thiene, Vicenza, Italy
Pediatric Department, Ospedale Maggiore
Bologna, , Italy
Pediatric Unit, Ospedale di Mestre
Mestre Venezia, , Italy
Pediatric Unit, Ospedale di Verona
Verona, , Italy
Countries
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References
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Chon CH, Lai FC, Shortliffe LM. Pediatric urinary tract infections. Pediatr Clin North Am. 2001 Dec;48(6):1441-59. doi: 10.1016/s0031-3955(05)70385-0.
Benfield MR, McDonald R, Sullivan EK, Stablein DM, Tejani A. The 1997 Annual Renal Transplantation in Children Report of the North American Pediatric Renal Transplant Cooperative Study (NAPRTCS). Pediatr Transplant. 1999 May;3(2):152-67. doi: 10.1034/j.1399-3046.1999.00011.x.
Wennerstrom M, Hansson S, Jodal U, Stokland E. Primary and acquired renal scarring in boys and girls with urinary tract infection. J Pediatr. 2000 Jan;136(1):30-4. doi: 10.1016/s0022-3476(00)90045-3.
Hoberman A, Wald ER, Hickey RW, Baskin M, Charron M, Majd M, Kearney DH, Reynolds EA, Ruley J, Janosky JE. Oral versus initial intravenous therapy for urinary tract infections in young febrile children. Pediatrics. 1999 Jul;104(1 Pt 1):79-86. doi: 10.1542/peds.104.1.79.
Downs SM. Technical report: urinary tract infections in febrile infants and young children. The Urinary Tract Subcommittee of the American Academy of Pediatrics Committee on Quality Improvement. Pediatrics. 1999 Apr;103(4):e54. doi: 10.1542/peds.103.4.e54.
Hohenfellner K, Hunley TE, Brezinska R, Brodhag P, Shyr Y, Brenner W, Habermehl P, Kon V. ACE I/D gene polymorphism predicts renal damage in congenital uropathies. Pediatr Nephrol. 1999 Aug;13(6):514-8. doi: 10.1007/s004670050649.
Bollgren I. Antibacterial prophylaxis in children with urinary tract infection. Acta Paediatr Suppl. 1999 Nov;88(431):48-52. doi: 10.1111/j.1651-2227.1999.tb01318.x.
Williams G, Lee A, Craig J. Antibiotics for the prevention of urinary tract infection in children: A systematic review of randomized controlled trials. J Pediatr. 2001 Jun;138(6):868-74. doi: 10.1067/mpd.2001.113785.
Williams GJ, Lee A, Craig JC. Long-term antibiotics for preventing recurrent urinary tract infection in children. Cochrane Database Syst Rev. 2001;(4):CD001534. doi: 10.1002/14651858.CD001534.
Ghiro L, Cracco AT, Sartor M, Comacchio S, Zacchello G, Dall'Amico R; Veneto Urinary Tract Infection Study Group. Retrospective study of children with acute pyelonephritis. Evaluation of bacterial etiology, antimicrobial susceptibility, drug management and imaging studies. Nephron. 2002 Jan;90(1):8-15. doi: 10.1159/000046308.
Montini G, Rigon L, Zucchetta P, Fregonese F, Toffolo A, Gobber D, Cecchin D, Pavanello L, Molinari PP, Maschio F, Zanchetta S, Cassar W, Casadio L, Crivellaro C, Fortunati P, Corsini A, Calderan A, Comacchio S, Tommasi L, Hewitt IK, Da Dalt L, Zacchello G, Dall'Amico R; IRIS Group. Prophylaxis after first febrile urinary tract infection in children? A multicenter, randomized, controlled, noninferiority trial. Pediatrics. 2008 Nov;122(5):1064-71. doi: 10.1542/peds.2007-3770.
Hewitt IK, Zucchetta P, Rigon L, Maschio F, Molinari PP, Tomasi L, Toffolo A, Pavanello L, Crivellaro C, Bellato S, Montini G. Early treatment of acute pyelonephritis in children fails to reduce renal scarring: data from the Italian Renal Infection Study Trials. Pediatrics. 2008 Sep;122(3):486-90. doi: 10.1542/peds.2007-2894.
Other Identifiers
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IRIS 2
Identifier Type: -
Identifier Source: org_study_id