Ignite Creation Date:
2024-05-05 @ 10:34 PM
Last Modification Date:
2024-10-26 @ 10:20 AM
Study NCT ID:
NCT01137929
Status:
WITHDRAWN
Last Update Posted:
2014-10-02
First Post:
2010-06-03
Brief Title:
Bacterial and Host Genetic Risk Factors in Acute Pyelonephritis
Sponsor:
Hans Pohl
Organization:
Childrens National Research Institute
Study Overview
Official Title:
Bacterial and Host Genetic Risk Factors That Predispose Children to Acute Pyelonephritis and Renal Scarring
Status:
WITHDRAWN
Status Verified Date:
2014-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Difficulty identifying eligible candidates
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
No single host or pathogen trait identified by previous research can be correlated with all cases of childhood acute pyelonephritis or APN ie kidneyupper 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 APNrenal scarring and improving patient outcomes
Detailed Description:
Urinary tract infections UTIs are the most common serious bacterial infections in young children with acute pyelonephritis or APN ie kidneyupper urinary tract infections and APN-associated renal scarring causing the most potential long-term damage to a childs health Approximately two-thirds of young children with febrile UTI UTIF or UTI presenting with fever will have APN making UTIF a major indicator of APN Other than the presence of fever it is currently difficult for physicians to determine which infant patients have or will develop APN and renal scarring Individual risk factors for the host eg uncircumcised males cytokine production and the pathogen eg presence of fimbriae for adhesion have individually been linked to APN and renal scarring but no single trait identified can be correlated with all cases Multiple factors on both sides of the host-pathogen relationship likely interact to determine the severity of the illness and the outcome Although the NIDDKNIH is currently funding two clinical trials to investigate the rate of recurrent UTI and the rate of renal scarring in children Randomized Intervention of Children with Vesicoureteral REflux RIVUR and Careful urinary Tract Infection Evaluation CUTIE neither of these studies will be able to identify the childs initial risk for having APN since patient recruitment will occur too long after treatment of the UTI Also neither study proposes as a specific goal to obtain bacteriological samples with which to study the microbes role in the pathogenesis of APN Thus to the best of our knowledge no comprehensive study exists that aims to analyze the relationships between the clinical manifestations of UTIs the host risk factors and immune response and the microbial species that cause these conditions Our proposed collaborative study between Childrens National Medical Center CNMC and the J Craig Venter Institute JCVI will collect clinical data as well as urine and blood samples from six distinct infant patient populations presenting with UTIF and correlate the clinical host and pathogen data for each patient with the severity of the disease and development of APN and renal scarring Metagenomic and genomic sequencing on the urine and isolated bacteria respectively will allow us to comprehensively study both the culturable and unculturable pathogens responsible for the UTI Using a genome-wide association study GWAS we will evaluate the polymorphisms of all known UTI-associated host genes paying particular attention to the immune system host genes previously identified as potentially linked to APN To correlate all collected data a publicly available database and website will be created to allow physicians and scientists to traverse the data Using the data collected in the database the final result of the study will be a clinical severity score to personalize diagnostic and treatment strategies for infants with UTIF with the goal of decreasing the morbidity of APN and improving patient outcomes An improved understanding of the microbial risk factors associated with APN and renal scarring will allow for better diagnostic approaches and improved methods for treating patients inclusive of novel medications in at risk individuals
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None