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

This study has been completed.
Sponsor:
Information provided by:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT00200616
First received: September 12, 2005
Last updated: June 30, 2008
Last verified: June 2008
  Purpose

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 Intervention
Urinary Tract Infection
Procedure: Antimicrobial prophylaxis

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

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

Estimated Enrollment: 232
Study Start Date: April 2001
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   up to 3 Years
Genders Eligible for Study:   Both
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:

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00200616

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

No publications provided

Responsible Party: Claude GUYOT, Nantes University Hospital
ClinicalTrials.gov Identifier: NCT00200616     History of Changes
Other Study ID Numbers: BRD/00/10-O
Study First Received: September 12, 2005
Last Updated: June 30, 2008
Health Authority: France: Ministry of Health

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

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

ClinicalTrials.gov processed this record on April 16, 2014