Evaluation of the Effectiveness of Antibiotic Prophylaxis in Children With a Previous Urinary Tract Infection
Recruitment status was: Active, not recruiting
|Urinary Tract Infections||Drug: antibiotic to reduce the recurrence of infection||Phase 4|
|Study Design:||Allocation: Randomized
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|
- 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.
- 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.
|Study Start Date:||May 2000|
|Estimated Study Completion Date:||July 2006|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00156546
|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|
|Pediatric Department, Ospedale Maggiore|
|- Pediatric Department, Ospedale di Bolzano|
|Pediatric Unit, Ospedale di Cuneo|
|Pediatric Unit, Ospedale di Mestre|
|Mestre Venezia, Italy|
|Nephrology, Dialysis and transplant Unit Pediatric Depatment,|
|Padova, Italy, 35128|
|Pediatric Unit, Ospedale di Ravenna|
|Pediatric Unit, Ospedale di Verona|
|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|