An observational study in Acute Pyelonephritis and Complicated Urinary Tract Infection, sponsored by Thomayer University Hospital. Status unknown at 1 site in Czechia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-06.
Sponsored by Thomayer University Hospital · Observational
The project aims to investigate bacterial metallophores as potential diagnostic markers of acute pyelonephritis and complicated urinary tract infections. These secondary metabolites are excreted by pathogenic microorganims in the course of infection for the uptake of iron and other metallic ions from the host. They are species-specific and can be detected in body fluids (including urine) by mass spectrometry. The potential contribution of this project is a culture-independent method for the diagnosis of the causative microbiological agent.
Acute pyelonephritis (AP) is a clinical syndrome characterized by fever, chills, nausea vomiting and costovertebral angle tenderness, bacteriuria and pyuria. The underlying pathophysiology is based on the presence of microbes in the renal parenchyma which may progress to sepsis. Complicated urinary tract infection (cUTI) is one accompanied by abnormalities of the urinary tract or host factors which make the eradication of the infection difficult.
The most common etiological agents include gram-negative enteric rods, i.e. E. coli, Klebsiella pneumoniae; and Enterococcus spp. Empirical antibiotic treatment should be targeted once culture and sensitivity results become available. This usually takes 24-48 hours, occasionally even 72 hours. Inadequate antibiotic treatment leads to higher mortality if the etiological agent is of a multi-drug resistant phenotype.
Metallophores are a major virulence factor of bacterial pathogens. These are chelating molecules secreted by the microbe for the uptake of iron, copper, and other metals from the host. E.g., siderophores aim at Fe3+ ions removal from the host protein molecules; the complex then adheres to specific extracellular receptors on the microbial cell and is internalized. Yersiniabactin is another metallophore which binds copper.
Proteomic analysis using mass spectrometry has been used in the detection of biomarkers for several pathological conditions: renal failure, post-transplant nephropathy, various malignancies etc. Metallophores can be detected by mass spectrometry.
79 studies on the registry are indexed under Pyelonephritis; 12 are open to participants now.
This study's planned enrollment of 90 is below the median of 153 across 15 observational studies indexed under Pyelonephritis.
Browse Pyelonephritis studies →Thomayer University Hospital is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
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Patients presenting to the department of urology and fulfilling eligibility criteria.
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Exclusion Criteria:
In-patients with AP or cUTI admitted for treatment to the hospital.
Out-patients seeking treatment for uncomplicated acute cystitis.
In-patients admitted to the ward without signs and symptoms of a urinary tract infection and with a negative urine culture result.
Detection of metallophores
The detection of metallophores in urine samples
Time frame: through study completion, an average of 1 year
Classification of microorganisms
Taxonomic classification of the pathogenic microorganism using its metallophores
Time frame: through study completion, an average of 1 year
Metallophores versus culture
The comparison of standard urinary culture results with those obtained from mass spectrometry analysis
Time frame: through study completion, an average of 1 year
Cases versus Controls 1 versus Controls 2
The comparison of the detection of metalophores in cases with AP/cUTI versus acute uncomplicated cystitis versus urinary tract infection-free individuals
Time frame: 1 year after study completion
Plan to share: No
This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Thomayer University Hospital