A Randomized Controlled Trial on Antibiotic Prophylaxis in Children With Vesico-Ureteral Reflux

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).

Timeline

Start

1999-11

Primary completion

2003-03

Completion

2007-03

Outcome

Missed primary endpoint

paper There were no differences in the risk for having at least 1 pyelonephritis episode between the intervention and control groups. PMID 18490378 ↗

paper Continuous antibiotic prophylaxis was ineffective in reducing the rate of pyelonephritis recurrence and the incidence of renal damage PMID 18490378 ↗

Publications

• Results Pennesi M, Travan L, Peratoner L, Bordugo A, Cattaneo A, Ronfani L, Minisini S, Ventura A; North East Italy Prophylaxis in VUR study group. Is antibiotic prophylaxis in children with vesicoureteral reflux effective in preventing pyelonephritis and renal scars? A randomized, controlled trial. Pediatrics. 2008 Jun;121(6):e1489-94. doi: 10.1542/peds.2007-2652. Epub 2008 May 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nitrofurantoin	Unknown	2 mg/kg	—
Subject	Sulfamethoxazole	Small molecule	5 mg/kg	—
Subject	Sulfamethoxazole	Small molecule	10 mg/kg	—
Subject	Trimethoprim	Small molecule	1 mg/kg	—
Subject	Trimethoprim	Small molecule	2 mg/kg	—

Indications