A Randomized Controlled Trial on Antibiotic Prophylaxis in Children With Vesico-Ureteral Reflux (NCT00382343) | Clinical Trial Compass
CompletedPhase 4
A Randomized Controlled Trial on Antibiotic Prophylaxis in Children With Vesico-Ureteral Reflux
Italy96 participantsStarted 1999-11
Plain-language summary
The aim of this study is to assess the effectiveness of antibiotic prophylaxis in preventing pyelonephritis and in avoiding the appearance of new scars in a sample of children under 36 months with vesico-ureteral reflux (VUR).
Who can participate
Age range1 Day – 30 Months
SexALL
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Inclusion Criteria:
* presence of vesico-ureteral reflux (VUR) grade II, III or IV, based on the International Classification, mono or bilateral, diagnosed between one day and 30 months of age after a first episode of acute pyelonephritis, or after birth during diagnostic procedures planned as a consequence of prenatal ultrasonographic evidence of pyelectasia.
Exclusion Criteria:
* previous episodes of urinary tract infection (UTI), even if only suspected (e.g. an episode of fever treated with antibiotics without performing urine culture);
* VUR grade I, because of the high probability of rapid spontaneous resolution;
* VUR grade V, as requested by the Technical Scientific Committee, concerned by the high incidence of associated renal dysplasia;
* recurrence of acute pyelonephritis before the first dimercaptosuccinic acid (DMSA) renal scan, if this was positive for scars.