NCT01137929|Withdrawn
Study Stopped
Difficulty identifying eligible candidates
Loading search results
Difficulty identifying eligible candidates
Sponsor study identifier
observational
0
0 countries
N/A
Study Start
November 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
No single host or pathogen trait identified by previous research can be correlated with all cases of childhood acute pyelonephritis or APN (i.e., kidney/upper urinary tract infections) and APN-associated renal scarring (the outcome with the highest morbidity), making it difficult for physicians to determine which patients will be affected. Our proposal is to comprehensively study the relationships between the clinical manifestations of urinary tract infections (UTIs), the host risk factors and immune response, and the microbial species that cause these conditions. The result of the study will be a clinical severity score to personalize diagnostic and treatment strategies for infants with UTI, with the goal of decreasing the morbidity of APN/renal scarring and improving patient outcomes.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 3, 2010
Actual (reported)June 7, 2010
Actual (reported)November 2014
Date type not reportedThis date has not been verified as actual or estimated.
November 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Incidence of acute pyelonephritis lesions
Children under two years of age will undergo a 99m-Tc-DMSA renal scan for the detection of acute pyelonephritis lesions within 72 hours of presentation to the ED for evaluation of a fever and positive urine culture. Based on finding the characteristic lesions (such as preservation of the renal contour but with diminished photopenia. This outcome measure will be aggregated with other bacterial and host related risk factors in order to identify the salient ones that result in morbidity from bladder infection.
< 72 hours after presentation with fever and positive urine culture
Incidence of renal cortical scarring
At least 6 months
This group of children who present with a febrile UTI will be found to have APN on DMSA renal scan and will also have VUR by VCUG and a renal scar on follow-up DMSA renal scan.
This group of children who present with a febrile UTI will be found to have APN on DMSA renal scan and will also have VUR by VCUG and NO renal scar on follow-up DMSA renal scan.
This group of children who present with a febrile UTI will be found to have APN on DMSA renal scan but who will NOT have VUR by VCUG; however they will have a renal scar on follow-up DMSA renal scan.
This group of children who present with a febrile UTI will be found to have APN on DMSA renal scan and will NOT have VUR by VCUG, NOR will they have a renal scar on follow-up DMSA renal scan.
This group of children who present with a febrile UTI will be found NOT to have APN on DMSA renal scan and will also have VUR by VCUG. They will not undergo a second DMSA scan since the first one is normal.
This group of children who present with a febrile UTI will be found NOT to have APN on DMSA renal scan and will also NOT have VUR by VCUG, NOR a renal scar on follow-up DMSA renal scan.
We will identify infants ≤ 2 years to be of particular risk for UTIF and renal scarring by virtue of a variety of risk factors, including age, gender, race, and underlying genetic risk factors and bacterial phenotypes.
Urine samples: Urine is routinely collected at the time of presentation with fever to diagnose UTI and an aliquot of this urine sample will be frozen for microbial genomic and metagenomic sequencing and analysis, that will allow us to identify unique/pathogenic/virulence factors in the genomes of these bacterial species when compared to non-pathogenic strains that have been subject to whole genome sequencing. Blood: DNA samples will be obtained at the time of renal scanning from the study subjects. The genomic DNA is used in PCR reactions and the resulting PCR products are screened for single nucelotide polymorphisms. Although we will be performing a genome wide association study, we will be particularly curious as to the behavior of SNP's among certain previously described candidates for the risk of renal scarring such as TLR2, TLR4, TGF-beta, and TNF-alpha. DNA samples will be stored for possible use in other future association studies.
0 participants (actual enrollment reported by the registry).
First Submitted
June 3, 2010
First Posted
June 7, 2010
Study Start
November 2014
Date type not reportedThis date has not been verified as actual or estimated.
Radiation-Free Technique for Evaluating Renal Scarring (RAFTERS)
Contact the study team to confirm eligibility.
Primary Completion
November 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 2, 2014
Record last verified: 2014-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: