Status:
COMPLETED
A Randomized Controlled Trial on Antibiotic Prophylaxis in Children With Vesico-Ureteral Reflux
Lead Sponsor:
IRCCS Burlo Garofolo
Conditions:
Pyelonephritis
Renal Scars
Eligibility:
All Genders
1-30 years
Phase:
PHASE4
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 ves...
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 eff...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00382343
Start Date
November 1 1999
End Date
March 1 2007
Last Update
April 28 2015
Active Locations (7)
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1
Sant'Orsola Hospital
Bologna, Bologna, Italy, 48138
2
Bufalini Hospital
Cesena, Cesena, Italy, 47023
3
San Polo Hospital
Monfalcone, Gorizia, Italy, 34170
4
Santa Maria degli Angeli Hospital
Pordenone, Pordenone, Italy, 33170