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)...
Brief Summary
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: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: July 2006
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Procedure: Antimicrobial prophylaxis
Outcome Measures for this Clinical Trial
Primary Measures
- End point : recurrence of urinary tract infection during the study period (0 รจ 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
Criteria for Participation 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 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
Clinical Trial Investigator Information
Lead Investigator: Nantes University Hospital Other
Overall Clinical Trial Officials and Contacts
Claude GUYOT, MD Principal Investigator Nantes University Hospital
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00200616
