Back to resultsUsefulness of Antimicrobial Prophylaxis in Children With Isolated Vesico-Ureteral Reflux.
Primary Purpose
Urinary Tract Infection
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Antimicrobial prophylaxis
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Tract Infection focused on measuring Urinary tract infection, Vesico-renal reflux, Child, Antimicrobial prophylaxis, Recurrence of urinary tract infection
Eligibility 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:
Sites / Locations
- Nantes University Hospital
Outcomes
Primary Outcome Measures
End point : recurrence of urinary tract infection during the study period (0 è 18 months)
Secondary Outcome Measures
1) Type of urinary tract infection (pyelonephritis or cystitis)
2) Evaluation of the quality of life with a validated questionnaire done at 9 months
Full Information
NCT ID
NCT00200616
First Posted
September 12, 2005
Last Updated
June 30, 2008
Sponsor
Nantes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00200616
Brief Title
Usefulness of Antimicrobial Prophylaxis in Children With Isolated Vesico-Ureteral Reflux.
Official Title
Antimicrobial Prophylaxis in Children With Isolated Vesico-Ureteral Reflux. A Randomised Prospective Study of Continuous Low Dose of Trimethoprim-Sulfamethoxazole Versus Surveillance.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
April 2001 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
July 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Nantes University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infection
Keywords
Urinary tract infection, Vesico-renal reflux, Child, Antimicrobial prophylaxis, Recurrence of urinary tract infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
232 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Antimicrobial prophylaxis
Primary Outcome Measure Information:
Title
End point : recurrence of urinary tract infection during the study period (0 è 18 months)
Secondary Outcome Measure Information:
Title
1) Type of urinary tract infection (pyelonephritis or cystitis)
Title
2) Evaluation of the quality of life with a validated questionnaire done at 9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility 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:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claude GUYOT, MD
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nantes University Hospital
City
Nantes
Country
France
12. IPD Sharing Statement
Learn more about this trial
Usefulness of Antimicrobial Prophylaxis in Children With Isolated Vesico-Ureteral Reflux.
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