Acute Pyelonephritis Clinical Trial
Official title:
Detection of Causative Agents of Acute Pyelonephritis Using Bacterial Metallophores
NCT number | NCT05674032 |
Other study ID # | TUH00064190 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 24, 2020 |
Est. completion date | December 2024 |
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.
Status | Recruiting |
Enrollment | 90 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - in-patient with clinical signs and symptoms of AP/cUTI or out-patient with clinical signs and symptoms of acute uncomplicated pyelonephritis or in-patient with no clinical signs of UTI and a negative standard urine culture result Exclusion Criteria: - inability to consent |
Country | Name | City | State |
---|---|---|---|
Czechia | Thomayer University Hospital | Praha |
Lead Sponsor | Collaborator |
---|---|
Thomayer University Hospital | Czech Academy of Sciences |
Czechia,
Bonkat G, Bartoletti R, Bruyère F, Cai T, Geerlings SE, Köves B, et al. Guidelines on Urological Infections. 2020. Vallejo-Torres L, Pujol M, Shaw E, Wiegand I, Vigo JM, Stoddart M, et al. Cost of hospitalised patients due to complicated urinary tract infections: A retrospective observational study in countries with high prevalence of multidrug-resistant Gram-negative bacteria: The COMBACTE-MAGNET, RESCUING study. BMJ Open 2018;8:1-9. https://doi.org/10.1136/bmjopen-2017-020251. Hrbacek J, Cermak P, Zachoval R. Current antibiotic resistance trends of uropathogens in central europe: Survey from a tertiary hospital urology department 2011-2019. Antibiotics 2020;9:1-11. https://doi.org/10.3390/antibiotics9090630. Hyun M, Noh CI, Ryu SY, Kim HA. Changing trends in clinical characteristics and antibiotic susceptibility of Klebsiella pneumoniae bacteremia. Korean J Intern Med 2018;33:595-603. Caza M, Kronstad J. Shared and distinct mechanisms of iron acquisition by bacterial and fungal pathogens of humans. Front Cell Infect Microbiol 2013;4:1-23. https://doi.org/10.3389/fcimb.2013.00080. Prichystal J, Schug K, Lemr K, Novak J, Havlicek V. Structural analysis of natural products. Anal Chem 2016;88:10338-46. Václavková J, Ozdian T, Hajdúch M, Džubák P. Body fluids as a source of prote-omic biomarkers of various diseases. Chem List 2020;114:209-15 Skriba A, Pluhacek T, Palyzova A, Novy Z, Lemr K, Hajduch M, et al. Early and non-invasive diagnosis of aspergillosis revealed by infection kinetics monitored in a rat model. Front Microbiol 2018;9:1-7. https://doi.org/10.3389/fmicb.2018.02356. Hrbacek J, Morais D, Cermak P, Hanacek V, Zachoval R. Alpha-diversity and microbial community structure of the male urinary microbiota depend on urine sampling method. Sci Rep 2021;11. https://doi.org/10.1038/s41598-021-03292-x.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Detection of metallophores | The detection of metallophores in urine samples | through study completion, an average of 1 year | |
Primary | Classification of microorganisms | Taxonomic classification of the pathogenic microorganism using its metallophores | through study completion, an average of 1 year | |
Secondary | Metallophores versus culture | The comparison of standard urinary culture results with those obtained from mass spectrometry analysis | through study completion, an average of 1 year | |
Secondary | 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 | 1 year after study completion |
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