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Data from the Randomized Intervention for Children with Vesico Ureteral Reflux (RIVUR) [(Version 2) https://doi.org/10.58020/zk68-8r70] reported here are available for request at the NIDDK Central Repository (NIDDK-CR) website, Resources for Research (R4R), https://repository.niddk.nih.gov/.
The RIVUR study was conducted by the study investigators and supported by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The resources from the RIVUR (https://doi.org/10.58020/zk68-8r70) study reported here were supplied by NIDDK Central Repository (NIDDK-CR) and are available for request at https://repository.niddk.nih.gov. This manuscript was not prepared under the auspices of the RIVUR study and does not necessarily reflect the opinions or views of the RIVUR study, NIDDK-CR, or NIDDK.
General Description
This multicenter, randomized, double-blind, placebo-controlled trial was designed to determine whether daily antimicrobial prophylaxis is superior to placebo in preventing recurrence of urinary tract infection (UTI) in children with vesicoureteral reflux (VUR). Patients were randomly assigned to treatment for 2 years with daily antimicrobial prophylaxis (trimethoprim-sulfamethoxazole) or placebo. The study was designed to recruit 600 children (approximately 300 in each treatment group. The protocol encouraged prompt evaluation of children with UTI symptoms and early therapy of culture-proven UTIs. It was expected that approximately 10% of children would have to discontinue study medication due to allergic reactions. Assuming a 20% placebo event rate and 10% non-adherence rate, the study had 83% power to detect an absolute 10% event rate in the antimicrobial prophylaxis group. If the placebo event rate was instead 25%, power was 97% to detect an absolute 10% event rate in the treated group, even if non-adherence were as high as 15%. The primary analysis is intention-to-treat with missing outcome data analyzed as UTI.
Objectives
In addition to collecting follow-up data on urinary tract infections, renal scarring and antimicrobial resistance, quality of life, medication adherence, safety parameters, utilization of health resources, and change in VUR were assessed periodically throughout the study.
Outcome Measure
Urinary tract infection recurrence; Renal scarring; antimicrobial resistance
Eligibility Criteria
Diagnosed first or second febrile or symptomatic UTI within 112 days prior to randomization; Presence of Grade I- IV VUR based on radiographic VCUG performed within 112 days of diagnosis of index UTI.
Outcome
Among children with vesicoureteral reflux after urinary tract infection, antimicrobial prophylaxis was associated with a substantially reduced risk of recurrence but not of renal scarring.
Research Area
Urologic Diseases
Study Type
Interventional
Study Sites
19
Study Start Date
2007-05
Study End Date
2014-05
Condition
Urinary Tract Infection, Vesicoureteral Reflux, Urinary Bladder Disorder
Keywords
vesicoureteral reflux (VUR), Renal Scarring, Trimethoprim-Sulfamethoxazole (Bactrim, Antimicrobial Resistance, Sulfatrim), Placebo, Antimicrobial Prophylaxis, Urniary Tract Infection Recurrence
NIDDK Division
KUH
607
Participants
Target Population
Children
Location statistics is not available for this study
Non-Public Documents (1)
Document Name | Description | Document Type | File Format |
|---|---|---|---|
Datasets (38)
Dataset Name | Description | # of Records | # of Variables | File Format(s) |
|---|---|---|---|---|
UTI Endpoints Classification and Adjudication Dataset | This dataset contains 1,563 observations from the UTI Endpoints Classification and Adjudication Form (ADJ) | 1563 | sas7bdat (217 KB); csv (348.6 KB) | |
Drug Discontinuation Dataset | This dataset contains 102 observations from the Drug Discontinuation Form (DDF) and includes data about all temporary and permanent discontinuations for the study drug | 102 | sas7bdat (17 KB); csv (11.41 KB) | |
Baseline Demographic Dataset | This dataset contains 604 observations from the Baseline Demographic Form (BDF). Data includes demographic variables and socio-economic factor. Interview was completed during the Baseline visit | 604 | sas7bdat (113 KB); csv (87.65 KB) | |
DMSA Sedation Dataset | This dataset contains 1,512 observations from the DMSA Sedation Form (DSF) and includes data about sedation usage during a participant’s DMSA procedure and basic information about the DMSA imaging | 1512 | sas7bdat (257 KB); csv (240.38 KB) | |
Physical Exam (Blood Pressure) Dataset | This dataset contains 607 observations and includes data about zscores and percentiles for the BMI, height, weight, and blood pressure measured on the Physical Exam Form (PEF) | 607 | sas7bdat (337 KB); csv (358.39 KB) | |
ICD Diagnosis Dataset | This dataset contains 5,064 observations. Data includes recoded ICD diagnosis text descriptions and/or corrected ICD9 codes for each medical care visit form (MCA/MCN) | 5064 | sas7bdat (369 KB); csv (101 KB) | |
Adverse Events Dataset | This dataset contains 876 observations from the Adverse Events Form (AEF). Data includes all reported study medication side effects, adverse events, or serious adverse events | 876 | sas7bdat (241 KB); csv (233.52 KB) | |
Life Impact Assessment Questionnaire (LIQ) Dataset | This dataset contains 1,581 observations from the Life Impact Assessment Questionnaire (LIQ). Data includes the participant’s recent health and mood, the parent’s quality of life in relation to the child’s VUR, and the child’s level of discomfort with symptoms and tests | 1581 | sas7bdat (241 KB); csv (208.86 KB) | |
Ultrasound Results Dataset | This dataset contains 608 observations of the adjudicated results from the Ultrasound Results Form (URF) | 608 | sas7bdat (113 KB); csv (113.58 KB) | |
Baseline Medical History Dataset | This dataset contains 605 observations from the Baseline Medical History Form (BMH). Data includes a participant’s natal history, medication history, voiding and bowel history and family medical history. | 605 | sas7bdat (85 KB); csv (107.73 KB) | |
Hard to Reach Follow-Up Dataset | This dataset contains 65 observations from the RIVUR Hard to Reach Follow-up Form (RFF). This questionnaire form is mailed to the participant if the RIVUR staff cannot reach the participant after several attempts. Data is similar to the Follow-up Form (FUP) | 65 | sas7bdat (49 KB); csv (12.48 KB) | |
VCUG Results Dataset | This dataset contains 1,058 observations of the adjudicated VCUG Results form (VRF) | 1058 | sas7bdat (257 KB); csv (208.06 KB) | |
DMSA Results Dataset | This dataset contains 1,500 observations of adjudicated results from the DMSA Results Form (DMF) | 1500 | sas7bdat (769 KB); csv (404 KB) | |
Medication Dispensing and Dosing (MDD) Dataset | This dataset contains 2,069 observations from the Medication Dispensing and Dosing Form (MDD). Data includes the dosage and the bottle codes for the study medication given to the participant | 2069 | sas7bdat (385 KB); csv (330.33 KB) | |
Urine Specimen Results Dataset | This dataset contains 2,777 observations. Data includes the results of the urinalysis and urine culture from the baseline and end-of-study visits as well as at any point during the study as reported on the Urine Specimen Results Form (USR) | 2777 | sas7bdat (1.78 MB); csv (2.09 MB) | |
Concomitant Medication Dataset | This dataset contains 7,584 observations from the Concomitant Medication Form (CMF). Data includes all medications being used by the participant including the RIVUR treatment | 7584 | sas7bdat (29.67 MB); csv (7.89 MB) | |
Participant Screening Log Dataset | This dataset contains 10,756 observations from the Participant Screening Log (PSL) which documents the initial eligibility of patients. | 10756 | sas7bdat (1.01 MB); csv (1.27 MB) | |
Specimen Collection Dataset | This dataset contains 2,543 observations from the Specimen Collection Form and contains data about the collection and shipping status of specimens | 2543 | sas7bdat (657 KB); csv (748.13 KB) | |
Blood Specimen Results Dataset | This dataset contains 2,450 observation from the Blood Specimen Results Form (BSR). Data includes laboratory results of the participant’s blood specimen | 2450 | sas7bdat (577 KB); csv (388.52 KB) | |
VCUG Sedation Dataset | This dataset contains 1,068 observations from the VCUG Sedation Form (VSF). Data includes sedation usage during a participant’s VCUG procedure | 1068 | sas7bdat (193 KB); csv (159.77 KB) | |
Medical Care Abstraction (MCA) Dataset | This dataset contains 3,009 observations from the Medical Care Abstraction Form (MCA) and includes data about a participant’s medical care visits | 3009 | sas7bdat (7.88 MB); csv (2.17 MB) | |
Treatment Failure Dataset | This dataset contains 41 observations from the Treatment Failure Form (TFF). Data includes treatment failures | 41 | sas7bdat (13 KB); csv (6.58 KB) | |
Protocol Scheduled Follow-Up Contact Dataset | This dataset contains 7,047 observations from the Protocol Scheduled Follow-up Contact Form (FUP). Data includes side effects/serious adverse events, medical care history, study medication status, interim voiding history, and interim bowel history for each scheduled follow-up contact | 7047 | sas7bdat (1.22 MB); csv (1.47 MB) | |
Exit Dataset | This dataset contains 536 observations from the Exit Form (EXF). Data includes future VUR treatment plans | 536 | sas7bdat (161 KB); csv (96.36 KB) | |
Secondary Microbial Sensitivity Dataset | This dataset contains 607 observations. Data includes all microbial sensitivity information for the secondary UTI organism | 607 | sas7bdat (257 KB); csv (105.3 KB) | |
Eligibility and Randomization Dataset | This dataset contains 607 observations from the Eligibility and Randomization Form (ERF) and contains data about the participants’ eligibility | 607 | sas7bdat (417 KB); csv (520.43 KB) | |
Outcomes Analysis Dataset | This dataset contains 607 observations. It was created to run analysis for the Antimicrobial Prophylaxis for Children with Vesicoureteral Reflux manuscript which appears in The New England Journal of Medicine, June 19, 2014 | 607 | sas7bdat (1009 KB); csv (636.79 KB) | |
DES (Dysfunctional Elimination Syndrome; Bladder and Bowel Dysfunction) Treatment Dataset | This dataset contains 223 observations from the DES (Dysfunctional Elimination Syndrome; Bladder and Bowel Dysfunction) Treatment Form (DTF). Data includes DES treatment based on the DVQ form | 223 | sas7bdat (25 KB); csv (21 KB) | |
Medical Care Notification (MCN) Dataset | This dataset contains 3,009 observations from the Medical Care Notification Form (MCN) and includes data about a participant’s medical care reported/received since the last contact. Linked to the MCA dataset | 3009 | sas7bdat (929 KB); csv (919.91 KB) | |
Dysfunctional Voiding Questionnaire (DVQ) Dataset | This dataset contains 630 observations from the Dysfunctional Voiding Questionnaire (DVQ). Data includes urine and bowel behaviors for participants who are toilet trained | 630 | sas7bdat (57 KB); csv (79.01 KB) | |
Derived Dataset | This dataset contains 607 observations and contains derived, recoded, or adjusted variables from multiple forms | 607 | sas7bdat (1.24 MB); csv (784.56 KB) | |
Antimicrobial Sensitivity Dataset | This dataset contains 18,368 observations. Data includes all antimicrobial sensitivity information from the sens_primary and sens_secondary datasets | 18368 | sas7bdat (3.39 MB); csv (556.94 KB) | |
Physical Exam Dataset | This dataset contains 2,499 observations from the Physical Exam Form (PEF). Data includes the results of a participant’s physical exam by a study physician | 2499 | csv (353.62 KB); sas7bdat (349 KB) | |
Medication Return Dataset | This dataset contains 1,535 observations from the Medication Return Form (MRF) and contains data about the return of the study drug. | 1535 | sas7bdat (385 KB); csv (290.31 KB) | |
Central Lab Blood Results Dataset | This dataset contains 909 observations from the Central Lab Blood Results Form (CLR). Data includes laboratory results of the participant’s blood specimen, which include the levels of creatinine, cystatin-C, and high sensitivity c reactive protein (hs-CRP) | 909 | sas7bdat (145 KB); csv (177.06 KB) | |
Consent Tracking Dataset | This dataset contains 1,043 observations from the Informed Consent Tracking Form (ICT) and contains data about the initial level of consent for the use of study data, specimens, and medical records | 1043 | sas7bdat (133 KB); csv (147.26 KB) | |
Rectal Swab Results Dataset | This dataset contains 1,801 observations from the Rectal Swab Results Form (RSR) and contains the Central Rectal Swab Laboratory results of the participant’s rectal swab specimens | 1801 | sas7bdat (253 KB); csv (287.82 KB) | |
Primary Microbial Sensitivity Dataset | This dataset contains 607 observations. Data includes all microbial sensitivity information for the primary UTI organism | 607 | sas7bdat (289 KB); csv (124.37 KB) |
Specimens (30,888)
Specimen | Count |
|---|---|
| Cells | 530 |
| DNA | 2873 |
| EBV Transformed Cell Lines | 4206 |
| Lymphocytes | 281 |
| Plasma | 1463 |
| Serum | 5515 |
| Urine | 16003 |
| Whole Blood | 17 |