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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by University of Padova.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Regione Veneto
IL Sogno di Stefano
Information provided by:
University of Padova
ClinicalTrials.gov Identifier:
NCT00156546
First received: September 7, 2005
Last updated: November 30, 2005
Last verified: September 2005
  Purpose

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 Intervention Phase
Urinary Tract Infections
Drug: antibiotic to reduce the recurrence of infection
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Padova:

Primary Outcome Measures:
  • 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:
  • 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.

Estimated Enrollment: 660
Study Start Date: May 2000
Estimated Study Completion Date: July 2006
Detailed Description:

Background

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.

  Eligibility

Ages Eligible for Study:   2 Months to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00156546

Locations
Italy
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
Investigators
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
  More Information

Publications:
Chon CH, Lai FC, Shortliffe LM. Pediatric urinary tract infections. Pediatr Clin North Am 48(6):1441-59, 2001.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00156546     History of Changes
Other Study ID Numbers: IRIS 2
Study First Received: September 7, 2005
Last Updated: November 30, 2005
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by University of Padova:
Urinary tract infections
Children
Antibiotic prophylaxis
Renal scintigraphy
Vesico ureteral reflux

Additional relevant MeSH terms:
Urinary Tract Infections
Infection
Urologic Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on July 31, 2014