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

Not Applicable

Completed

• Conditions: Urinary Tract Infection

• Registration Number: NCT00200616
• Lead Sponsor: Nantes University Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2001-04
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Primary Completion: 2006-07
• Study Completion: 2006-07
• Status Verified: 2008-06
• Last Update Submitted: 2008-06-30
• Last Update Posted: 2008-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 232

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

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Nantes University Hospital; 🇫🇷 Nantes, France