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

NCT ID: NCT00200616

Last Updated: 2008-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

232 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-04-30

Study Completion Date

2006-07-31

Brief Summary

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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

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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.

Conditions

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Urinary Tract Infection

Keywords

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Urinary tract infection Vesico-renal reflux Child Antimicrobial prophylaxis Recurrence of urinary tract infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Antimicrobial prophylaxis

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

1 Day

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Nantes University Hospital

Principal Investigators

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Claude GUYOT, MD

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

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Nantes University Hospital

Nantes, , France

Site Status

Countries

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France

Other Identifiers

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BRD/00/10-O

Identifier Type: -

Identifier Source: org_study_id