Official Title: “Antimicrobial Prophylaxis in Children With Isolated Vesico-Ureteral Reflux. A Randomised Prospective Study of Continuous Low Dose of Trimethoprim-Sulfamethoxazole Versus Surveillance.”

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 Type: Interventional

Study Design: Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment

Study Primary Completion Date: July 2006

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.

Intervention(s) in this Clinical Trial

• Procedure: Antimicrobial prophylaxis

Primary Measures

• End point : recurrence of urinary tract infection during the study period (0 è 18 months)

Secondary Measures

• 1) Type of urinary tract infection (pyelonephritis or cystitis)
• 2) Evaluation of the quality of life with a validated questionnaire done at 9 months

Inclusion Criteria:

• Children less than 3 years old
• First proved urinary tract infectionIsolated vesico-ureteral reflux
• Parents have been fully informed and have given written informed consent to participate in the study

Exclusion Criteria:

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: 3 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Nantes University Hospital

Overall Clinical Trial Officials and Contacts

Claude GUYOT, MD Principal Investigator Nantes University Hospital  

Information obtained from ClinicalTrials.gov on September 08, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00200616

Study ID Number: BRD/00/10-O

ClinicalTrials.gov Identifier: NCT00200616

Health Authority: France: Ministry of Health