Usefulness of Antimicrobial Prophylaxis in Children With Isolated Vesico-Ureteral Reflux.
Randomized, prospective, multicenter study in order to assess the usefulness of antimicrobial prophylaxis in children with isolated vesico-ureteral reflux (grade III or less).
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Antimicrobial Prophylaxis in Children With Isolated Vesico-Ureteral Reflux. A Randomised Prospective Study of Continuous Low Dose of Trimethoprim-Sulfamethoxazole Versus Surveillance.|
- End point : recurrence of urinary tract infection during the study period (0 è 18 months)
- 1) Type of urinary tract infection (pyelonephritis or cystitis)
- 2) Evaluation of the quality of life with a validated questionnaire done at 9 months
|Study Start Date:||April 2001|
|Study Completion Date:||July 2006|
|Primary Completion Date:||July 2006 (Final data collection date for primary outcome measure)|
A voiding cystourethrogram was performed for each child less than 3 years old with a first urinary tract infection. In case of vesico-ureteral reflux, a randomization was done between continuous antimicrobial prophylaxis with low dose of trimethoprim-sulfamethoxazole and no antibioprophylaxis. Duration of follow up was 18 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00200616
|Nantes University Hospital|
|Principal Investigator:||Claude GUYOT, MD||Nantes University Hospital|