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

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ClinicalTrials.gov Identifier: NCT00200616
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : July 1, 2008
Sponsor:
Information provided by:
Nantes University Hospital

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).

Condition or disease Intervention/treatment Phase
Urinary Tract Infection Procedure: Antimicrobial prophylaxis Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 232 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2001
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2006

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Primary Outcome Measures :
  1. End point : recurrence of urinary tract infection during the study period (0 è 18 months)

Secondary Outcome Measures :
  1. 1) Type of urinary tract infection (pyelonephritis or cystitis)
  2. 2) Evaluation of the quality of life with a validated questionnaire done at 9 months


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Ages Eligible for Study:   up to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:


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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00200616


Locations
France
Nantes University Hospital
Nantes, France
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Claude GUYOT, MD Nantes University Hospital

Responsible Party: Claude GUYOT, Nantes University Hospital
ClinicalTrials.gov Identifier: NCT00200616     History of Changes
Other Study ID Numbers: BRD/00/10-O
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: July 1, 2008
Last Verified: June 2008

Keywords provided by Nantes University Hospital:
Urinary tract infection
Vesico-renal reflux
Child
Antimicrobial prophylaxis
Recurrence of urinary tract infection

Additional relevant MeSH terms:
Infection
Urinary Tract Infections
Vesico-Ureteral Reflux
Urologic Diseases
Urinary Bladder Diseases
Anti-Infective Agents
Trimethoprim, Sulfamethoxazole Drug Combination
Anti-Bacterial Agents
Anti-Infective Agents, Urinary
Renal Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents