Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR) (NCT00405704) | Clinical Trial Compass
CompletedPhase 3
Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR)
United States607 participantsStarted 2007-05
Plain-language summary
In this 2-year, multisite, randomized, placebo-controlled trial involving 607 children with vesicoureteral reflux that was diagnosed after a first or second febrile or symptomatic urinary tract infecton, we evaluated the efficacy of Trimethoprim-Sulfamethoxazole (TMP-SMZ) prophylaxis in preventing recurrences (primary outcome). Secondary outcomes were renal scarring, treatment failure (a composite of recurrences and scarring), and antimicrobial resistance.
Who can participate
Age range2 Months – 71 Months
SexALL
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Inclusion Criteria:
* Age at randomization: at least 2 months, but less than 6 years of age. Note that children as young as 1 month were screened for the study.
* Diagnosed first or second febrile or symptomatic UTI within 112 days prior to randomization
* Presence of Grade I- IV VUR based on radiographic voiding cystourethrogram (VCUG) performed within 112 days of diagnosis of index UTI.
* Appropriately treated index febrile or symptomatic UTI
Exclusion Criteria:
* Index UTI diagnosis more than 112 days prior to randomization
* History of more than two UTIs prior to randomization
* For patients less than 6 months of age at randomization, gestational age less than 34 weeks
* Co-morbid urologic anomalies
* Hydronephrosis, SFU Grade 4
* Ureterocele
* Urethral valve
* Solitary kidney
* Profoundly decreased renal size unilaterally on ultrasound (based on 2 standard deviations below the mean for age and length) performed within 112 days after diagnosis of index UTI
* Multicystic dysplastic kidney
* Neurogenic bladder
* Pelvic kidney or fused kidney
* Known sulfa allergy, inadequate renal or hepatic function, Glucose-6-phosphate dehydrogenase deficiency or other conditions that are contraindications for use of TMP-SMZ
* History of other renal injury/disease
* Unable to complete the study protocol
* Congenital or acquired immunodeficiency
* Underlying anomalies or chronic diseases that could potentially interfere with response to therapy such as chronic gastrointestinal condition…
What they're measuring
1
Recurrent Febrile or Symptomatic Urinary Tract Infection During 2-year Follow-up
Timeframe: 2 years
Trial details
NCT IDNCT00405704
SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)