Vesicoureteral Reflux Clinical Trial
Official title:
Bacterial and Host Genetic Risk Factors That Predispose Children to Acute Pyelonephritis and Renal Scarring
Verified date | October 2014 |
Source | Children's Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | November 2016 |
Est. primary completion date | November 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 2 Months to 24 Months |
Eligibility |
Inclusion Criteria: - Infants admitted to the inpatient ward at Children's National Medical Center for the treatment of a febrile urinary tract infection (see definitions) will be screened for inclusion into the research protocol. - UTIF: A UTIF will require the presence of - (1) fever and/or symptoms consistent with UTI, - (2) pyuria based on urinalysis, and - (3) culture-proven infection with a single organism. Specifically, the study definition of UTIF will require: - Fever: A documented temperature of at least 100.4 °F or 38°C, measured anywhere on the body either at home or at doctor's office. Positive dipstick analysis: Pyuria on urinalysis (>10 WBC/mm3 (uncentrifuged specimen) OR >5 WBC/hpf (centrifuged specimen), OR >1+ leukocyte esterase on dipstick). - Culture documentation of UTI: Evidence of bacteria (>5 x 104 CFU/mL (catheterized or suprapubic aspiration urine specimen). Bag collected specimens will not be acceptable Exclusion Criteria: - Infants who do not conform to the above inclusion criteria and who have co-morbidities such as duplication abnormalities, diabetes mellitus, over weight status, anatomical defects of the urinary tract and neuropathic bladder dysfunction. |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hans Pohl |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Incidence of renal cortical scarring | Since the lesions associated with acute pyelonephritis can resolve up to 6 months following infection, we will stress the importance of obtaining these delayed scans for the purpose of ascertaining whether the inflammation has resulted in a fixed lesion, termed a renal scar. | At least 6 months | No |
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