NCT00200616

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
232

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2001

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

July 1, 2008

Status Verified

June 1, 2008

Enrollment Period

5.3 years

First QC Date

September 12, 2005

Last Update Submit

June 30, 2008

Conditions

Urinary Tract Infection

Keywords

Urinary tract infectionVesico-renal refluxChildAntimicrobial prophylaxisRecurrence of urinary tract infection

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

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

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

Interventions

Antimicrobial prophylaxisPROCEDURE

Eligibility Criteria

Age1 Day - 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nantes University Hospital

Nantes, France

Location

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Claude GUYOT, MD

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

April 1, 2001

Primary Completion

July 1, 2006

Study Completion

July 1, 2006

Last Updated

July 1, 2008

Record last verified: 2008-06

Locations

FR(1)