Acute PyelonephritisNCT05674032
Bacterial Metallophores in the Diagnosis of Acute Pyelonephritis
An observational study of Acute Pyelonephritis and Complicated Urinary Tract Infection, run by Thomayer University Hospital at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Pyelonephritis, Complicated Urinary Tract Infection
- How many people
- 90 participants
- Where
- 1 siteCzechia
- Study dates
- 24 Jun 2020to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients presenting to the department of urology and fulfilling eligibility criteria.
Who may be able to join
- 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
Who cannot join
- inability to consent
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Thomayer University Hospital
Prague, 14059
Jan Hrbacek, PhD., +420261083688, jan.hrbacek@ftn.cz
Jiri Stejskal, M.D., +420261083688, jiri.stejskal@ftn.cz
About this study
Official title: Detection of Causative Agents of Acute Pyelonephritis Using Bacterial Metallophores
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.
Read the detailed description
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.
- Keywords
- metallophores, mass spectrometry, acute pyelonephritis, complicated urinary tract infection, siderophores, yersiniabactin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of metallophores
The detection of metallophores in urine samples
Measured: through study completion, an average of 1 year
Classification of microorganisms
Taxonomic classification of the pathogenic microorganism using its metallophores
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
Metallophores versus culture
The comparison of standard urinary culture results with those obtained from mass spectrometry analysis
Measured: 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
Measured: 1 year after study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start24 Jun 2020
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute PyelonephritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomayer University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Czech Academy of Sciences
- Responsible party
- Principal investigator, Jan Hrbacek, M.D., Thomayer University Hospital
- Investigators
- Jan Hrbacek, PhD., Study director, Thomayer University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05674032
- Sponsor's protocol ID
- TUH00064190
- Status last verified
- Jan 2023
- First submitted
- 22 Sep 2022
- Last updated
- 6 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Causative Agents of Acute Pyelonephritis Using Bacterial Metallophores
- ClinicalTrials.gov ID
- NCT05674032
- Acronym / sponsor ID
- TUH00064190
- Keywords
- metallophores, mass spectrometry, acute pyelonephritis, complicated urinary tract infection, siderophores, yersiniabactin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Thomayer University HospitalUniversity, hospital or other
- Collaborators
- Czech Academy of Sciences
- Study start
- 24 Jun 2020 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 6 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to the department of urology and fulfilling eligibility criteria.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- inability to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Detection of metallophores
Time frame: through study completion, an average of 1 year
The detection of metallophores in urine samples
Classification of microorganisms
Time frame: through study completion, an average of 1 year
Taxonomic classification of the pathogenic microorganism using its metallophores
2 secondary outcomes
Metallophores versus culture
Time frame: through study completion, an average of 1 year
Cases versus Controls 1 versus Controls 2
Time frame: 1 year after study completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2023.
- BackgroundBonkat 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Hrbacek, PhD. study director
Thomayer University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Pyelonephritis and Complicated Urinary Tract Infection, run by Thomayer University Hospital at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jan Hrbacek, PhD. (+420261083688, honzahrbacek@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of metallophores (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05674032, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2023.