Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00382343
Status:
COMPLETED
Last Update Posted:
2015-04-28
First Post:
2006-09-28
Brief Title:
A Randomized Controlled Trial on Antibiotic Prophylaxis in Children With Vesico-Ureteral Reflux
Sponsor:
IRCCS Burlo Garofolo
Organization:
IRCCS Burlo Garofolo
Study Overview
Official Title:
Antibiotic Prophylaxis After Acute Pyelonephritis for Prevention of Urinary Tract Infections in Children With Vesico-Ureteral Reflux
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
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 ie 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None