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NIH: National Institute of Diabetes and Digestive and Kidney Diseases
NIDDK Central Repository
Citation
Carpenter, Myra (2024). Careful Urinary Tract Infection Evaluation (CUTIE) (Version 3) [Dataset] NIDDK Central Repository. https://doi.org/10.58020/6gqa-cn96
Data Availability Statement
Data from the Careful Urinary Tract Infection Evaluation (CUTIE) [(Version 3) https://doi.org/10.58020/6gqa-cn96] reported here are available for request at the NIDDK Central Repository (NIDDK-CR) website, Resources for Research (R4R), https://repository.niddk.nih.gov/.
Acknowledgment Statement
The CUTIE 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 CUTIE (https://doi.org/10.58020/6gqa-cn96) 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 CUTIE study and does not necessarily reflect the opinions or views of the CUTIE study, NIDDK-CR, or NIDDK.
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General Description

Urinary tract infections (UTIs) are the most common serious bacterial infections in young children. When accompanied by a fever, there is an increased likelihood of a UTI also infecting the kidneys; between 15 and 52% of these children will develop kidney scarring as a result.

The Careful Urinary Tract Infection Evaluation (CUTIE) study was an observational study designed to determine why some children develop kidney scars after urinary tract infections (UTIs). The study was aimed at understanding which children were at the greatest risk of developing renal scarring following a UTI, so physicians can provide targeted therapies and appropriate interventions. Children between 2 months and 6 years of age who had a first or second UTI in the past 4 months were eligible for enrollment in the study. Participants were followed for 2 years through the course of five study visits, during which they were required to undergo a physical exam and provide information about recent medical history and quality of life via a questionnaire completed by parents. Additionally, blood and urine biospecimens were collected to monitor kidney function, and renal scans were performed to assess the development of kidney damage.

The CUTIE study was ancillary to the RIVUR (Randomized Intervention for Children with Vesicoureteral Reflux) study, which compared antibiotic prophylaxis to placebo in a cohort of children with a history of UTI and vesicoureteral reflux. The CUTIE study focused specifically on children with a history of UTI who did not have vesicoureteral reflux. More information about the RIVUR study is available on the NIDDK repository website.

Objectives

The primary aim of the study was to determine the risk factors for developing renal scarring in children as a result of a UTI.

Outcome Measure

Medical history, quality of life, kidney function, and development of kidney damage were measured to the determine risk factors for renal scarring.

Eligibility Criteria

Children between 2 months and 6 years of age were eligible for the study if they meet the following criteria:

  • Has had no more than 2 UTIs with either fever or symptoms
  • Was treated for the first UTI for at least seven days with an effective antibiotic
  • No history of VUR
  • No history of other renal injury or serious disease
  • No allergies to sulfa medications
Outcome

VUR and BBD were risk factors for recurrent UTI, especially when they appeared in combination. Strategies for preventing recurrent UTI include antimicrobial prophylaxis and treatment of BBD.

Research Area

Multidisciplinary Research, Urologic Diseases, Kidney Disease

Study Type

Observational

Study Sites

3

Condition

Urinary Tract Infection, Vesicoureteral Reflux

Keywords

Renal Scarring, Urogenital Disease, Recurrent UTI, Persistent UTI, Kidney Scar, Urinary Tract Infection (UTI), Randomized Intervention for Children with Vesicoureteral Reflux (RIVUR)

NIDDK Division

KUH

Network
RIVUR Network (RIVUR Network)

195
Participants
Target Population
Children

Public Documents Table
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Compliance
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Datasets (28)
Datasets Table
Dataset Name
Description
# of Records
# of Variables
File Format(s)
Blood Specimen Results Form (BSR) Data
Data from Blood Specimen Results Form (BSR) containing the local laboratory results of the participant’s blood specimen, including blood count (CBC), and metabolic/electrolyte results351sas7bdat (61 KB); csv (31.04 KB)
Informed Consent Tracking Form (ICT) Data
Data from Informed Consent Tracking Form (ICT) indicating consent status, specimen consent, and medical records and data use consent402sas7bdat (61 KB); csv (30.29 KB)
Enrollment Data
Data collected during participant enrollment into CUTIE Study195sas7bdat (257 KB); csv (117.25 KB)
Medical Care Abstraction Form (MCA) Data
Data from Medical Care Abstraction Form (MCA) indicating information based on medical records / chart review on all medical care reported and documented initially on an MCN form682sas7bdat (1.81 MB); csv (240.41 KB)
DES Treatment Form (DTF) Data
Data from DES Treatment Form (DTF) containing information regarding possible DES treatment for female participants with a DVQ score >6 or male participants with a DVQ score >9, which is determined based on data from the DVQ68sas7bdat (9 KB); csv (4.22 KB)
Secondary Organism Antimicrobial Sensitivity Index Data
Data collected on secondary organism antimicrobial sensitivity index195sas7bdat (97 KB); csv (14.11 KB)
Medical Care Notification Form (MCN) Data
Data from Medical Care Notification Form (MCN) indicating all medical care information reported or received since the last study contact, including in-clinic CUTIE sick visits682sas7bdat (225 KB); csv (117.92 KB)
Specimen Collection Form (SCF) Data
Data from Specimen Collection Form (SCF) indicating collection information of all protocol specific specimens, including blood, urine, and rectal swabs356sas7bdat (97 KB); csv (69.41 KB)
Diagnosis Data
Data collected on participant diagnosis and ICD9 code1097sas7bdat (81 KB); csv (17.65 KB)
Baseline Demographic Form (BDF) Data
Data from Baseline Demographic Form (BDF) includes demographic variables of gender, ethnicity and race, and includes socio-economic factors, such as income and education195sas7bdat (49 KB); csv (17.64 KB)
Baseline Medical History Form (BMHA) Data
Data from Baseline Medical History Form (BMHA) indicating patient natal history, medication history, voiding history, bowel history, and family medical history195sas7bdat (37 KB); csv (21.21 KB)
Scar Scan Based v2 Data
Data collected on during scar scan procedure1501sas7bdat (77 KB); csv (44.4 KB)
Protocol Scheduled Follow-Up Contact Form (FUP) Data
Data from Protocol Scheduled Follow-Up Contact Form (FUP) indicating patient medical history, study medication status, and method of contact2326sas7bdat (401 KB); csv (209.78 KB)
DMSA Sedation Form (DSF) Data
Data from DMSA Sedation Form (DSF) indicating required information on possible sedation for every DMSA scan340sas7bdat (65 KB); csv (31.99 KB)
LIA Questionnaire (LIQ) Data
Data collected from LIA questionnaire completed by child's parent or guardian444sas7bdat (61 KB); csv (37.35 KB)
Participant Screening Log (PSL) Data
Data collected from participant screening log indicating final eligibility disposition of all children who were considered and screened2355sas7bdat (193 KB); csv (157.35 KB)
Primary Organism Antimicrobial Sensitivity Index Data
Data collected on primary organism antimicrobial sensitivity index195sas7bdat (113 KB); csv (23.81 KB)
DMSA Results Form (DMF) Data
Data from DMSA Results Form (DMF) indicating local report information and DMSA image readings results339sas7bdat (193 KB); csv (48.29 KB)
Ultrasound Results Form (URF) Data
Data from Ultrasound Results Form (URF) containing imaging results191sas7bdat (49 KB); csv (22.62 KB)
Urine Specimen Results Form (USR) Data
Data from Urine Specimen Results Form (USR) indicating urinalysis results obtained from medical records abstraction685sas7bdat (481 KB); csv (231.75 KB)
CUTIE Outcomes Manuscript Data
Data collected on CUTIE Outcomes Manuscript500sas7bdat (353 KB); csv (191.24 KB)
Physical Exam Form (PEF) Data
Data collected during participant physical exam indicating vital signs and health status assessments629sas7bdat (97 KB); csv (59.38 KB)
Organism Antimicrobial Sensitivity Index Data
Data collected on primary organism antimicrobial sensitivity index9968sas7bdat (1.01 MB); csv (204.32 KB)
Concomitant Medications Form (CMF) Data
Data from Concomitant Medications Form (CMF) that contains all medications being used by the participant, including medication that the participant was prescribed prior to enrollment, also includes vaccinations and anesthetic drugs used in medical procedures2520sas7bdat (9.89 MB); csv (1.04 MB)
Baseline Physical Exam Data
Data collected on baseline physical exam results195sas7bdat (129 KB); csv (65.18 KB)
DV Questionnaire (DVQ) Data
DV Questionnaire (DVQ) data indicating baseline information about the child204sas7bdat (25 KB); csv (15.78 KB)
Adverse Events Form (AEF) Data
Data from Adverse Events Form (AEF) on occurrence, seriousness, and side effects of all reported study adverse events or serious adverse events281sas7bdat (81 KB); csv (45.69 KB)
CUTIE Eligibility and Enrollment Form (CEE) Data
Data from CUTIE Eligibility and Enrollment Form (CEE) that verifies the participants’ eligibility criteria, such as participant’s age, history of UTIs, timing of index UTI, etc.195sas7bdat (129 KB); csv (86.28 KB)
Specimens (10,185)
Specimens Table
Specimen
Count
Cells171
DNA1174
EBV Transformed Cell Lines1355
Lymphocytes100
Plasma654
Serum1762
Urine4969