COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00200616
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : July 1, 2008
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.

Layout table for study information
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

Resource links provided by the National Library of Medicine

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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:

Information from the National Library of Medicine

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 identifier (NCT number): NCT00200616

Layout table for location information
Nantes University Hospital
Nantes, France
Sponsors and Collaborators
Nantes University Hospital
Layout table for investigator information
Principal Investigator: Claude GUYOT, MD Nantes University Hospital
Layout table for additonal information
Responsible Party: Claude GUYOT, Nantes University Hospital Identifier: NCT00200616    
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
Antimicrobial prophylaxis
Recurrence of urinary tract infection
Additional relevant MeSH terms:
Layout table for MeSH terms
Urinary Tract Infections
Vesico-Ureteral Reflux
Urologic Diseases
Urinary Bladder Diseases
Anti-Infective Agents
Anti-Bacterial Agents