Evaluation of the Effectiveness of Antibiotic Prophylaxis in Children With a Previous Urinary Tract Infection

NCT00156546 | Unknown Phase 4

• 1 other identifier: IRIS 2
• Study Type: interventional
• Target: 660
• Locations: 1 country
• Sites: 16

Brief Summary

Our hypothesis is that long-term antimicrobial prophylaxis does not reduce the recurrence of infection and the risk of appearance of kidney scars in children with a documented previous upper UTI.

Conditions

Urinary Tract Infections

Keywords

Urinary tract infections; Children; Antibiotic prophylaxis; Renal scintigraphy; Vesico ureteral reflux

Outcome Measures

Primary Outcomes (1)

• The primary end-point is UTI Recurrence Rate during the 12-month observation period and the Development of renal damage (parenchymal scar) after 12 months.

Secondary Outcomes (1)

• The secondary objectives are the comparison, in terms of efficacy and effectiveness, between two antimicrobial agents that are currently approved for prophylactic use: co-trimoxazole 15 mg/kg daily versus amoxicillin + clavulanic acid 15 mg/kg daily.

Interventions

antibiotic to reduce the recurrence of infection DRUG

Eligibility Criteria

• Age: 2 Months - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age between 2 months and 6 years
• 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

You may not qualify if:

• Patients with chronic renal insufficiency or  30% relative function of one kidney at DMSA scan
• 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

Sponsors & Collaborators

• University of Padova: lead
• Regione Veneto: collaborator
• IL Sogno di Stefano: collaborator

Study Sites (16)

Pediatric Unit, Ospedale di Belluno

Belluno, Belluno, Italy

Location

Pediatric Unit, Ospedale di Bentivoglio

Bentivoglio, Bologna, Italy

Location

- Pediatric Department, Ospedale di Bolzano

Bolzano, Bolzano, Italy

Location

Pediatric Unit, Ospedale di Cuneo

Cuneo, Cuneo, Italy

Location

Pediatric Unit, Ospedale di Este - Monselice

Monselice, Padova, Italy

Location

Nephrology, Dialysis and transplant Unit Pediatric Depatment,

Padua, Padova, 35128, Italy

Location

Pediatric Unit, Ospedale di Piove di Sacco e Chioggia

Piove di Sacco, Padova, Italy

Location

Pediatric Unit, Ospedale di Ravenna

Ravenna, Ravenna, Italy

Location

Pediatric Unit, Ospedale di Castelfranco

Castelfranco Veneto, Treviso, Italy

Location

Pediatric Unit, Ospedale di Motta di Livenza

Motta Di Livenza Oderzo, Treviso, Italy

Location

Pediatric Unit, Ospedale di Dolo

Dolo, Venezia, Italy

Location

Pediatric Unit, Ospedale di Soave

Soave, Verona, Italy

Location

Pediatric Unit, Ospedale di Schio/Thiene

Thiene, Vicenza, Italy

Location

Pediatric Department, Ospedale Maggiore

Bologna, Italy

Location

Pediatric Unit, Ospedale di Mestre

Mestre Venezia, Italy

Location

Pediatric Unit, Ospedale di Verona

Verona, Italy

Location

Related Publications (12)

• 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.

  PMID: 11732124 BACKGROUND

• 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.

  PMID: 10389139 BACKGROUND

• 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.

  PMID: 10636970 BACKGROUND

• 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.

  PMID: 10390264 BACKGROUND

• 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.

  PMID: 10103346 BACKGROUND

• 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.

  PMID: 10452281 BACKGROUND

• 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.

  PMID: 10588271 BACKGROUND

• 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.

  PMID: 11391331 BACKGROUND

• 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.

  PMID: 11687116 BACKGROUND

• 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.

  PMID: 11744799 BACKGROUND

• 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.

  PMID: 18977988 DERIVED

• 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.

  PMID: 18762516 DERIVED

MeSH Terms

Conditions

Urinary Tract Infections; Vesico-Ureteral Reflux

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder Diseases

Study Officials

• Graziella Zacchello, Professor

  Departement of Pediatrics, University of Padova

  STUDY CHAIR

• Antonella Toffolo, Dr

  Pediatric Unit Ospedale di Oderzo (TV) Italy

  PRINCIPAL INVESTIGATOR

• Alessandro Calderan, Dr

  PRINCIPAL INVESTIGATOR

• Giovanni Montini, Dr

  Nephrology, Dialysis and Transplant Unit, Pediatric Departement, Azienda Ospedaliera-Università, Padova

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 7, 2005
• First Posted: September 12, 2005
• Study Start: May 1, 2000
• Study Completion: July 1, 2006
• Last Updated: December 1, 2005

Record last verified: 2005-09

Locations

IT (16)