Usefulness of Antimicrobial Prophylaxis in Children With Isolated Vesico-Ureteral Reflux.

Overview

Randomized, prospective, multicenter study in order to assess the usefulness of antimicrobial prophylaxis in children with isolated vesico-ureteral reflux (grade III or less).

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2006

Detailed Description

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.

Interventions

  • Procedure: Antimicrobial prophylaxis

Clinical Trial Outcome Measures

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

Participating in This Clinical Trial

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: All

Minimum Age: 1 Day

Maximum Age: 3 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Nantes University Hospital
  • Provider of Information About this Clinical Study
    • Claude GUYOT, Nantes University Hospital
  • Overall Official(s)
    • Claude GUYOT, MD, Principal Investigator, Nantes University Hospital

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