Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-24 @ 7:58 PM
NCT ID:
NCT00405704
Eligibility Criteria:
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 conditions (i.e., malabsorption, inflammatory bowel disease), liver or kidney failure, or malignancy.
* Complex cardiac disease as defined in the Manual of Procedures.
* Any known syndromes associated with VUR or bladder dysfunction
* Index UTI not successfully treated
* Unlikely to complete follow-up
* Family history of anaphylactic reaction to sulfa medications
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Months
Maximum Age:
71 Months
Study:
NCT00405704
Study Brief:
Protocol Section:
NCT00405704