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

Sponsor:	Nantes University Hospital
Information provided by:	Nantes University Hospital
ClinicalTrials.gov Identifier:	NCT00200616

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:

MedlinePlus related topics: GERD Urinary Tract Infections

Drug Information available for: Sulfamethoxazole Trimethoprim

U.S. FDA Resources

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 February 09, 2012