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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00156546
Recruitment Status : Unknown
Verified September 2005 by University of Padova.
Recruitment status was:  Active, not recruiting
First Posted : September 12, 2005
Last Update Posted : December 1, 2005
Regione Veneto
IL Sogno di Stefano
Information provided by:
University of Padova

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.

Condition or disease Intervention/treatment Phase
Urinary Tract Infections Drug: antibiotic to reduce the recurrence of infection Phase 4

Detailed Description:


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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 660 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of the Effectiveness of Antibiotic Prophylaxis in Children With a History of Upper Urinary Tract Infections:a Multicentre Randomised Study
Study Start Date : May 2000
Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00156546

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Pediatric Unit, Ospedale di Bentivoglio
Bentivoglio, Bologna, Italy
Pediatric Unit, Ospedale di Este - Monselice
Monselice, Padova, Italy
Pediatric Unit, Ospedale di Piove di Sacco e Chioggia
Piove di Sacco, Padova, 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 Unit, Ospedale di Belluno
Belluno, Italy
Pediatric Department, Ospedale Maggiore
Bologna, Italy
- Pediatric Department, Ospedale di Bolzano
Bolzano, Italy
Pediatric Unit, Ospedale di Cuneo
Cuneo, Italy
Pediatric Unit, Ospedale di Mestre
Mestre Venezia, Italy
Nephrology, Dialysis and transplant Unit Pediatric Depatment,
Padova, Italy, 35128
Pediatric Unit, Ospedale di Ravenna
Ravenna, Italy
Pediatric Unit, Ospedale di Verona
Verona, Italy
Sponsors and Collaborators
University of Padova
Regione Veneto
IL Sogno di Stefano
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Study Chair: Graziella Zacchello, Professor Departement of Pediatrics, University of Padova
Principal Investigator: 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

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00156546    
Other Study ID Numbers: IRIS 2
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: December 1, 2005
Last Verified: September 2005
Keywords provided by University of Padova:
Urinary tract infections
Antibiotic prophylaxis
Renal scintigraphy
Vesico ureteral reflux
Additional relevant MeSH terms:
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Communicable Diseases
Urinary Tract Infections
Urologic Diseases
Anti-Bacterial Agents
Anti-Infective Agents