Pyelonephritis Clinical Trial
Official title:
Antibiotic Prophylaxis After Acute Pyelonephritis for Prevention of Urinary Tract Infections in Children With Vesico-Ureteral Reflux.
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).
In recent years, the effectiveness of continuous antibiotic prophylaxis in children with
vesico-ureteral reflux (VUR) has been intensely discussed. The question is not only whether
antibiotics are effective in preventing recurrent urinary tract infections (UTI), but also
whether they alter the natural history of disease and help to prevent the appearance of new
kidneys scars. The evidence on the effectiveness of antibiotic prophylaxis is scanty:
randomised controlled trials (RCT) published until now are poorly designed and carried out
in very heterogeneous samples of children, i.e. spanning from 6 months to 14-18 years of age
and pooling patients with and without VUR. A recently updated Cochrane Systematic Review
concludes that high quality RCTs are needed to determine the effectiveness of long-term
antibiotics for the prevention of UTIs in susceptible children. Moreover, the presence of
VUR has not been firmly shown to be a risk factor for recurrence of pyelonephritis, and a
direct association between VUR and the presence of scars or the appearance of new scars has
not been demonstrated; there is just an association between VUR of grade IV-V and prenatal
renal dysplasia, almost exclusively in male infants. In spite of this uncertainty, several
practice guidelines recommend long term antibiotic prophylaxis in children with different
degrees of VUR.
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 VUR.
Comparison: In a multicentre trial, 100 patients with VUR diagnosed with cystourethrography
after a first episode of acute pyelonephritis or for prenatal evidence of pyelectasia will
be assigned randomly to receive prophylaxis or not. Randomization will be carried out using
a centralized minimization procedure to balance for sex, age group and VUR grade.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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