Bacterial Metallophores in the Diagnosis of Acute Pyelonephritis
Detection of Causative Agents of Acute Pyelonephritis Using Bacterial Metallophores
1 other identifier
observational
90
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2020
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 24, 2020
CompletedFirst Submitted
Initial submission to the registry
September 22, 2022
CompletedFirst Posted
Study publicly available on registry
January 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedJanuary 6, 2023
January 1, 2023
4.4 years
September 22, 2022
January 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Detection of metallophores
The detection of metallophores in urine samples
through study completion, an average of 1 year
Classification of microorganisms
Taxonomic classification of the pathogenic microorganism using its metallophores
through study completion, an average of 1 year
Secondary Outcomes (2)
Metallophores versus culture
through study completion, an average of 1 year
Cases versus Controls 1 versus Controls 2
1 year after study completion
Study Arms (3)
Cases
In-patients with AP or cUTI admitted for treatment to the hospital.
Control group 1
Out-patients seeking treatment for uncomplicated acute cystitis.
Control group 2
In-patients admitted to the ward without signs and symptoms of a urinary tract infection and with a negative urine culture result.
Eligibility Criteria
Patients presenting to the department of urology and fulfilling eligibility criteria.
You may qualify if:
- 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
You may not qualify if:
- inability to consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Thomayer University Hospitallead
- Czech Academy of Sciencescollaborator
Study Sites (1)
Thomayer University Hospital
Prague, 14059, Czechia
Related Publications (1)
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.
BACKGROUND
Biospecimen
urine samples
Study Officials
- STUDY DIRECTOR
Jan Hrbacek, PhD.
Thomayer University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 22, 2022
First Posted
January 6, 2023
Study Start
June 24, 2020
Primary Completion
December 1, 2024
Study Completion
December 1, 2024
Last Updated
January 6, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share