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NCT00200616 Clinical Trial

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

Urinary Tract Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00200616
Other study ID # BRD/00/10-O
Secondary ID
Status Completed
Phase N/A
First received September 12, 2005
Last updated June 30, 2008
Start date April 2001
Est. completion date July 2006

Study information
Verified date June 2008
Source Nantes University Hospital
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Completed
Enrollment 232
Est. completion date July 2006
Est. primary completion date July 2006
Accepts healthy volunteers No
Gender Both
Age group N/A to 3 Years
Eligibility 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:

Study Design

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

Related Conditions & MeSH terms

Intervention

Procedure:
• Antimicrobial prophylaxis

Locations
Country Name City State
France Nantes University Hospital Nantes

Sponsors (1)
Lead Sponsor Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary End point : recurrence of urinary tract infection during the study period (0 è 18 months)
Secondary 1) Type of urinary tract infection (pyelonephritis or cystitis)
Secondary 2) Evaluation of the quality of life with a validated questionnaire done at 9 months
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