Evaluation of the Effectiveness of Antibiotic Prophylaxis in Children With a Previous Urinary Tract Infection
Recruitment status was Active, not recruiting
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.
Urinary Tract Infections
Drug: antibiotic to reduce the recurrence of infection
|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|
- 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.
|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|