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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00200616
Enrollment
232
Registered
2005-09-20
Start date
2001-04-30
Completion date
2006-07-31
Last updated
2008-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Tract Infection

Keywords

Urinary tract infection, Vesico-renal reflux, Child, Antimicrobial prophylaxis, Recurrence of urinary tract infection

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.

Interventions

PROCEDUREAntimicrobial prophylaxis

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Days to 3 Years
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

Design outcomes

Primary

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

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026