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

Nantes University Hospital (NUH)

Status: Completed

Conditions: Urinary Tract Infection

Treatments: Procedure: Antimicrobial prophylaxis

Study type: Interventional

Funder types: Other

Identifiers

NCT00200616

BRD/00/10-O

Details and patient eligibility

About

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 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.

Sex: All

Ages: 1 day to 3 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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:

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)