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

History of Changes

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

June 30, 2008

Start Date ^ICMJE

April 2001

Primary Completion Date

July 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00200616 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Antimicrobial Prophylaxis in Children With Isolated Vesico-Ureteral Reflux. A Randomised Prospective Study of Continuous Low Dose of Trimethoprim-Sulfamethoxazole Versus Surveillance.

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Urinary Tract Infection

Intervention ^ICMJE

Procedure: Antimicrobial prophylaxis

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

232

Completion Date

July 2006

Primary Completion Date

July 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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:

Gender

Both

Ages

up to 3 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT00200616

Other Study ID Numbers ^ICMJE

BRD/00/10-O

Has Data Monitoring Committee

Responsible Party

Claude GUYOT, Nantes University Hospital

Study Sponsor ^ICMJE

Nantes University Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Claude GUYOT, MD

Nantes University Hospital

Information Provided By

Nantes University Hospital

Verification Date

June 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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