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

N/ACompletedNCT00200616

Nantes University Hospital232 enrolled

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).

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

232

Conditions

Urinary Tract Infection

Interventions

Antimicrobial prophylaxisPROCEDURE

Eligibility

Sex: ALLMin age: 1 DayMax age: 3 Years

Medical Language ↔ Plain English

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:

Locations (1)

Nantes University Hospital

Nantes, France

Outcomes

Primary Outcomes

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

Secondary Outcomes

1) Type of urinary tract infection (pyelonephritis or cystitis)

2) Evaluation of the quality of life with a validated questionnaire done at 9 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.