Pyelonephritis

The NATURAL Study is a prospective, observational, pragmatic study of RNA biomarkers of infections to aid in the diagnosis of abdominal pain. Summary of Research Study: Hypothesis: A genomic-derived panel of 6 RNA biomarkers present in stabilized whole blood will provide diagnostic information about the presence of bacterial, biofilm, and viral infections in the abdomen. We hypothesize that biomarkers will be more than 90% sensitive with a high (\>90%) negative predictive value for IAI. Research Design: The project design is a prospective, pragmatic, observational study. The NATURAL Study will be sponsored by True Bearing Diagnostics, Inc., and performed at 5 or more academic medical centers. Patients with suspected intra-abdominal infections (IAIs), such as appendicitis, diverticulitis, acute cholecystitis, pancreatitis, peritonitis, pyelonephritis, and abscess are candidates for this study. This is a broad category of patients that are defined by the suspicion of an internal abdominal infection, usually involving some type of advanced imaging analysis, such as CT scan or ultrasound. All participants will be consented for this observational, minimal-risk study prior to venipuncture. Ultimately, The NATURAL Study will determine the positive agreement (\~sensitivity) and negative agreement (\~specificity) of the TruNAV RNA biomarkers in relation to the clinical diagnosis of the presence or absence of an IAI, based on CT scans and/or surgical confirmation, the current standard of care for diagnosis of IAI. Objective: To validate a novel RNA fingerprint in ED patients with suspected IAIs. The NATURAL Study is designed to determine the accuracy of novel RNA biomarkers for diagnosis of IAI in patients suspected of having IAI. Subgroup analysis will analyse RNA biomarker for multiple types of actual and suspected IAIs (appendicitis, diverticulitis, acute cholecystitis, pancreatitis, peritonitis, pyelonephritis, and abscess.) Subjects: Approximately 1,000 ED patients presenting with abdominal pain that are candidates to receive CT or other confirmatory diagnostics will be enrolled.

Temocillin, a 6-alpha-methoxypenicillin derivative of ticarcillin, is a narrow-spectrum antibiotic, primarily restricted to Enterobacterales. Therefore, its prescription for the treatment of febrile urinary tract infections requiring hospitalization in pediatrics appears interesting. However, and despite marketing authorization in pediatrics for the treatment of complicated urinary tract infections (including acute pyelonephritis), the pharmacokinetic parameters of this antibiotic have not been specifically evaluated in pediatrics, and the optimal dose is not known in this population. Through this study, we propose to determine the pharmacokinetic parameters of temocillin in children aged 0-15 years with a febrile urinary tract infection due to Gram-negative rod (GNR), without sepsis but requiring hospitalization. The results will help to establish dose recommendations for temocillin in the pediatric population, based on age and renal function.

The investigators propose a new imaging method for children born with congenital anomalies of the urinary tract that is a rapid, injection-, sedation-, and radiation-free alternative: the quick renal MRI. This proposal hypothesizes that the quick renal MRI has high validity compared to current radiologic standard for renal infection and scarring, the 99mTechnetium-dimercaptosuccinic acid (99mTc- DMSA) renal scan in the detection of acute renal infections and scars. If the quick renal MRI is accurate, it could potentially replace the DMSA scan for those specific questions and ease the burden of testing for children with chronic renal disease. Findings from these studies will provide preliminary data and rationale for a multi-centered study to further test this new technology. Participants will be 0-21 years of age and can expect to be on study for from 1 week (if enrolled in Aim 1) to 6 months (if enrolled in Aim 2).