Pyelonephritis AcuteNCT04651244
Diagnostic Imaging of Acute Pyelonephritis
An observational study of Pyelonephritis Acute, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
Acute pyelonephritis is important to recognize and treat quickly. Today the diagnosis is primarily clinical and often challenging. Sometimes acute pyelonephritis is complicated by obstruction leading to hydronephrosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pyelonephritis Acute
- What is being tested?
- MRI, Ultrasound performed by a radiologist and Point of care ultrasound
- How many people
- 19 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2021to 1 Jun 2022
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be included among patients admitted at the ED of three Danish hospitals in the Region of Southern Denmark: the ED in Kolding, Lillebælt Hospital, the ED in Aabenraa, Hospital Sønderjylland, and the ED in Odense, Odense University Hospital. A Danish ED corresponds to an acute medical ward. Either a general practitioner or a prehospital emergency medical service refers patients visiting a Danish ED, or patients get admitted because they called the emergency centre telephone number (1-1-2).
Who may be able to join
- Suspicion of acute pyelonephritis by ED physician
- Suspicion of urinary tract infection by ED physician and systemic affection (e.g. fever, sepsis
Who cannot join
- Unable to undergo an MRI
- Known allergy to US contrast
- If the attending physician considers that participation will delay a life-saving treatment or patient needs direct transfer to the intensive care unit.
- Admission within the last 14 days
- Verified COVID-19 disease within 14 days before admission
- Pregnant women
- Severe immunodeficiencies: Primary immunodeficiencies and secondary immunodeficiencies (HIV positive CD4 <200, Patients receiving immunosuppressive treatment (ATC L04A), Corticosteroid treatment (>20 mg/day prednisone or equivalent for >14 days within the last 30 days), Chemotherapy within 30 days)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Imaging of Acute Pyelonephritis - Part of the INDEED Study (Infectious Diseases in Emergency Departments)
Acute pyelonephritis is important to recognize and treat quickly. Today the diagnosis is primarily clinical and often challenging. Sometimes acute pyelonephritis is complicated by obstruction leading to hydronephrosis. The aim of this study is to investigate whether ultrasound scanning conducted by a radiologist can diagnose acute pyelonephritis. Also, the investigators will investigate whether health care professionals with basic ultrasound skills can diagnose hydronephrosis by point-of-care ultrasound scanning in patients suspected of acute pyelonephritis.
Read the detailed description
Acute pyelonephritis (APN) is an acute infection in the upper urinary tract, which quite frequently is seen in emergency departments (ED). Most often, an infection of the bladder ascends to the kidneys causing APN. In rarer cases, APN occurs because of a hematogenous spread of bacteria. It is important to identify and treat APN quickly to prevent progression to sepsis, renal failure and ultimately death. Today, primarily APN diagnosis consists of a clinical identification. This is often supported by unspecific blood and urine tests such as C reactive protein (CRP) and leucocytes and urine dipstick. A positive urine culture verifies the APN diagnosis. This diagnostic process is challenging as frequently symptoms are weak and atypical and there is a waiting period for unspecific diagnostic methods and culture results. Complicating an APN diagnosis is asymptomatic bacteriuria, a confusing condition, common in the elderly. Therefore, the empirical treatment initiated often treats a potentially wide range of infections including APN. Currently, the Danish ED do not use diagnostic imaging to confirm APN. Ultrasound scanning (US) by a radiologist rules out other complicating factors such as obstruction or renal abscess. Further imaging is reserved for complicated cases with no response to the initial treatment. Both Computed Tomography (CT) scanning and Magnetic Resonance Imaging (MRI) can visualize inflammation in the kidneys. Generally, CT is considered the optimal imaging modality in complicated APN cases. The radiation dose-related to a CT must be considered if this imaging technique is to be used as a primary diagnostic tool. MRI appears to be equally or more satisfactory in identifying the inflammatory changes related to APN. However, this investigative tool is more expensive and time-consuming, and often not readily available.
Ultrasound (US) has a lot of advantages in an acute medical setting. It can be utilised at the bedside and is a gentle technique. Conventional grayscale US is not ideal when trying to identify APN. However, more specialized US techniques increase the diagnostic value of US. These techniques include the Doppler US and the contrast-enhanced US (CEUS). Studies suggest that CEUS can identify APN equally to contrast-enhanced CT. Therefore, US has the potential to become relevant in the investigation of patients with a suspected kidney infection in the ED.
This study aims to investigate whether additional diagnostic imaging, in particular US, of patients admitted to the ED with suspected APN will assist in a more reliable diagnosis. Furthermore, it will investigate if point-of-care US of the kidneys by an investigator with basic US skill can assist a more rapid recognition of hydronephrosis in APN patients with complicating obstruction.
The investigators will invite patients admitted with suspected APN to participate in this study, which will include three additional scans. The first is a point of care US of the kidneys by a study assistant to assess the presence or absence of hydronephrosis. The second is a US by a specialist from the Radiology Department using both Doppler US and CEUS. The third scan is a reference standard MRI of the kidneys at the Radiology Department. This will be performed at a similar time (or as close as possible) to the radiologist US. The MRI will be conducted on a 1,5 T MRI scanner and include the following sequences: planning, Dixon, T1 mapping, T2, T2 mapping, apparent diffusion coefficient (ADC) (100, 400, 800), MRI angio (3D VIBE), and Phase Contrast.
These additional imaging findings will be evaluated in relation to the clinical findings.
- Conditions
- Pyelonephritis Acute
- Being tested
- MRI, Ultrasound performed by a radiologist, Point of care ultrasound
- Keywords
- Complicated urinary tract infection, Hydronephrosis, Contrast enhanced Ultrasound, Ultrasound, Diagnostic imaging
- Medical subject headings
- Hydronephrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
Gold standard for identifying inflammatory changes in patients with acute pyelonephritis
Ultrasound performed by a radiologistDiagnostic test
US performed by a radiologist including standard grayscale evaluation of the kidneys, Doppler US and contrast enhanced US (CEUS).
Point of care ultrasoundDiagnostic test
Point of care US by a study assistant with basic ultrasound skills and training to access the presence or absence of hydronephrosis. If hydronephrosis is present it will be graded into one of four categories.
| Study group | Role | What they receive |
|---|---|---|
| Patients with suspected acute pyelonephritis | Patients admitted in the ED with suspected infection, where the initial medical assessment raises suspicion of APN. Receives: Diagnostic Test: MRI; Diagnostic Test: Ultrasound performed by a radiologist; Diagnostic Test: Point of care ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of inflammatory changes in the kidneys on CEUS compared to MRI
Findings on the investigations will be registered on predefined templates. Both kidneys will be described regarding signs of inflammation, where we e.g. look at perfusion on CEUS, and edema or renal lesions on MRI.
Results of the investigations on the same kidneys are compared in order to access specificity and sensitivity of findings on CEUS compared to MRI.
The conducting/describing radiologist will be informed of some standardized clinical and paraclinical parameters (e.g. fever, CRP, flank pain, relevant comorbidity), but will be blinded to the results of the other imaging investigations.
Measured: Routine descriptions of the scans will be available within about 48 hours from recruitment. Focused descriptions and comparison are conducted within 6 months after investigation.
Comparison of inflammatory changes in the kidneys on gray scale US and spectral doppler compared to the reference standard MRI
Findings on the investigations will be registered on predefined templates. Both kidneys will be described regarding signs of inflammation, where we e.g. look at perfusion and resistance on US, and edema or renal lesions on MRI.
Results of the investigations on the same kidneys are compared in order to access specificity and sensitivity of findings on US compared to MRI.
The conducting/describing radiologist will be informed of some standardized clinical and paraclinical parameters (e.g. fever, CRP, flank pain, relevant comorbidity), but will be blinded to the results of the other imaging investigations.
Measured: Routine descriptions of the scans will be available within about 48 hours from recruitment. Focused descriptions and comparison is conducted within 6 after investigation.
Sensitivity and specificity of point-of-care ultrasound on identifying hydronephrosis compared to MRI
How many of hydronephroses in patients suspected of APN is discovered by point of care US performed by an investigator with basic point of care US skills? MRI of the kidneys conducted maximum 24 hours after the point of care US is used as reference standard.
Measured: Within 48 hours
Secondary outcomes (1)
Proportion of patients with APN and hydronephrosis
We use the gold standard investigation, MRI, to evaluate the number of APN patients who also have hydronephrosis.
Measured: Within 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start1 Mar 2021
- Primary completion28 Feb 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pyelonephritis AcuteStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Backer Mogensen, Study chair, Institute for Regional Health Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04651244
- Sponsor's protocol ID
- SHS-ED-11a-2020
- Status last verified
- Sep 2022
- First submitted
- 25 Nov 2020
- Last updated
- 16 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Claeys KC, Blanco N, Morgan DJ, Leekha S, Sullivan KV. Advances and Challenges in the Diagnosis and Treatment of Urinary Tract Infections: the Need for Diagnostic Stewardship. Curr Infect Dis Rep. 2019 Mar 5;21(4):11. doi: 10.1007/s11908-019-0668-7.
PubMed 30834993Rathod SB, Kumbhar SS, Nanivadekar A, Aman K. Role of diffusion-weighted MRI in acute pyelonephritis: a prospective study. Acta Radiol. 2015 Feb;56(2):244-9. doi: 10.1177/0284185114520862. Epub 2014 Jan 17.
PubMed 24443116Cruz J, Figueiredo F, Matos AP, Duarte S, Guerra A, Ramalho M. Infectious and Inflammatory Diseases of the Urinary Tract: Role of MR Imaging. Magn Reson Imaging Clin N Am. 2019 Feb;27(1):59-75. doi: 10.1016/j.mric.2018.09.001. Epub 2018 Oct 29.
PubMed 30466913Quaia E, Correas JM, Mehta M, Murchison JT, Gennari AG, van Beek EJR. Gray Scale Ultrasound, Color Doppler Ultrasound, and Contrast-Enhanced Ultrasound in Renal Parenchymal Diseases. Ultrasound Q. 2018 Dec;34(4):250-267. doi: 10.1097/RUQ.0000000000000383.
PubMed 30169495Mitterberger M, Pinggera GM, Colleselli D, Bartsch G, Strasser H, Steppan I, Pallwein L, Friedrich A, Gradl J, Frauscher F. Acute pyelonephritis: comparison of diagnosis with computed tomography and contrast-enhanced ultrasonography. BJU Int. 2008 Feb;101(3):341-4. doi: 10.1111/j.1464-410X.2007.07280.x. Epub 2007 Oct 17.
PubMed 17941932Kazmierski B, Deurdulian C, Tchelepi H, Grant EG. Applications of contrast-enhanced ultrasound in the kidney. Abdom Radiol (NY). 2018 Apr;43(4):880-898. doi: 10.1007/s00261-017-1307-0.
PubMed 28856401Skjot-Arkil H, Heltborg A, Lorentzen MH, Cartuliares MB, Hertz MA, Graumann O, Rosenvinge FS, Petersen ERB, Ostergaard C, Laursen CB, Skovsted TA, Posth S, Chen M, Mogensen CB. Improved diagnostics of infectious diseases in emergency departments: a protocol of a multifaceted multicentre diagnostic study. BMJ Open. 2021 Sep 30;11(9):e049606. doi: 10.1136/bmjopen-2021-049606.
PubMed 34593497
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Imaging of Acute Pyelonephritis - Part of the INDEED Study (Infectious Diseases in Emergency Departments)
- ClinicalTrials.gov ID
- NCT04651244
- Acronym / sponsor ID
- SHS-ED-11a-2020
- Conditions
- Pyelonephritis Acute
- Keywords
- Complicated urinary tract infection, Hydronephrosis, Contrast enhanced Ultrasound, Ultrasound, Diagnostic imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 3 Dec 2020 (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.
Acute pyelonephritis is important to recognize and treat quickly. Today the diagnosis is primarily clinical and often challenging. Sometimes acute pyelonephritis is complicated by obstruction leading to hydronephrosis. The aim of this study is to investigate whether ultrasound scanning conducted by a radiologist can diagnose acute pyelonephritis. Also, the investigators will investigate whether health care professionals with basic ultrasound skills can diagnose hydronephrosis by point-of-care ultrasound scanning in patients suspected of acute pyelonephritis.
Detailed description
Acute pyelonephritis (APN) is an acute infection in the upper urinary tract, which quite frequently is seen in emergency departments (ED). Most often, an infection of the bladder ascends to the kidneys causing APN. In rarer cases, APN occurs because of a hematogenous spread of bacteria. It is important to identify and treat APN quickly to prevent progression to sepsis, renal failure and ultimately death. Today, primarily APN diagnosis consists of a clinical identification. This is often supported by unspecific blood and urine tests such as C reactive protein (CRP) and leucocytes and urine dipstick. A positive urine culture verifies the APN diagnosis. This diagnostic process is challenging as frequently symptoms are weak and atypical and there is a waiting period for unspecific diagnostic methods and culture results. Complicating an APN diagnosis is asymptomatic bacteriuria, a confusing condition, common in the elderly. Therefore, the empirical treatment initiated often treats a potentially wide range of infections including APN. Currently, the Danish ED do not use diagnostic imaging to confirm APN. Ultrasound scanning (US) by a radiologist rules out other complicating factors such as obstruction or renal abscess. Further imaging is reserved for complicated cases with no response to the initial treatment. Both Computed Tomography (CT) scanning and Magnetic Resonance Imaging (MRI) can visualize inflammation in the kidneys. Generally, CT is considered the optimal imaging modality in complicated APN cases. The radiation dose-related to a CT must be considered if this imaging technique is to be used as a primary diagnostic tool. MRI appears to be equally or more satisfactory in identifying the inflammatory changes related to APN. However, this investigative tool is more expensive and time-consuming, and often not readily available.
Ultrasound (US) has a lot of advantages in an acute medical setting. It can be utilised at the bedside and is a gentle technique. Conventional grayscale US is not ideal when trying to identify APN. However, more specialized US techniques increase the diagnostic value of US. These techniques include the Doppler US and the contrast-enhanced US (CEUS). Studies suggest that CEUS can identify APN equally to contrast-enhanced CT. Therefore, US has the potential to become relevant in the investigation of patients with a suspected kidney infection in the ED.
This study aims to investigate whether additional diagnostic imaging, in particular US, of patients admitted to the ED with suspected APN will assist in a more reliable diagnosis. Furthermore, it will investigate if point-of-care US of the kidneys by an investigator with basic US skill can assist a more rapid recognition of hydronephrosis in APN patients with complicating obstruction.
The investigators will invite patients admitted with suspected APN to participate in this study, which will include three additional scans. The first is a point of care US of the kidneys by a study assistant to assess the presence or absence of hydronephrosis. The second is a US by a specialist from the Radiology Department using both Doppler US and CEUS. The third scan is a reference standard MRI of the kidneys at the Radiology Department. This will be performed at a similar time (or as close as possible) to the radiologist US. The MRI will be conducted on a 1,5 T MRI scanner and include the following sequences: planning, Dixon, T1 mapping, T2, T2 mapping, apparent diffusion coefficient (ADC) (100, 400, 800), MRI angio (3D VIBE), and Phase Contrast.
These additional imaging findings will be evaluated in relation to the clinical findings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with suspected acute pyelonephritis | – | Diagnostic Test: MRI, Diagnostic Test: Ultrasound performed by a radiologist, Diagnostic Test: Point of care ultrasoundPatients admitted in the ED with suspected infection, where the initial medical assessment raises suspicion of APN. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be included among patients admitted at the ED of three Danish hospitals in the Region of Southern Denmark: the ED in Kolding, Lillebælt Hospital, the ED in Aabenraa, Hospital Sønderjylland, and the ED in Odense, Odense University Hospital. A Danish ED corresponds to an acute medical ward. Either a general practitioner or a prehospital emergency medical service refers patients visiting a Danish ED, or patients get admitted because they called the emergency centre telephone number (1-1-2).
Key inclusion criteria (2 listed)
- Suspicion of acute pyelonephritis by ED physician
- Suspicion of urinary tract infection by ED physician and systemic affection (e.g. fever, sepsis
Key exclusion criteria (7 listed)
- Unable to undergo an MRI
- Known allergy to US contrast
- If the attending physician considers that participation will delay a life-saving treatment or patient needs direct transfer to the intensive care unit.
- Admission within the last 14 days
- Verified COVID-19 disease within 14 days before admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIGold standard for identifying inflammatory changes in patients with acute pyelonephritis | Diagnostic test | Patients with suspected acute pyelonephritis |
| Ultrasound performed by a radiologistUS performed by a radiologist including standard grayscale evaluation of the kidneys, Doppler US and contrast enhanced US (CEUS). | Diagnostic test | Patients with suspected acute pyelonephritis |
| Point of care ultrasoundPoint of care US by a study assistant with basic ultrasound skills and training to access the presence or absence of hydronephrosis. If hydronephrosis is present it will be graded into one of four categories. | Diagnostic test | Patients with suspected acute pyelonephritis |
Primary outcome
Comparison of inflammatory changes in the kidneys on CEUS compared to MRI
Time frame: Routine descriptions of the scans will be available within about 48 hours from recruitment. Focused descriptions and comparison are conducted within 6 months after investigation.
Findings on the investigations will be registered on predefined templates. Both kidneys will be described regarding signs of inflammation, where we e.g. look at perfusion on CEUS, and edema or renal lesions on MRI. Results of the investigations on the same kidneys are compared in order to access specificity and sensitivity of findings on CEUS compared to MRI. The conducting/describing radiologist will be informed of some standardized clinical and paraclinical parameters (e.g. fever, CRP, flank pain, relevant comorbidity), but will be blinded to the results of the other imaging investigations.
Comparison of inflammatory changes in the kidneys on gray scale US and spectral doppler compared to the reference standard MRI
Time frame: Routine descriptions of the scans will be available within about 48 hours from recruitment. Focused descriptions and comparison is conducted within 6 after investigation.
Findings on the investigations will be registered on predefined templates. Both kidneys will be described regarding signs of inflammation, where we e.g. look at perfusion and resistance on US, and edema or renal lesions on MRI. Results of the investigations on the same kidneys are compared in order to access specificity and sensitivity of findings on US compared to MRI. The conducting/describing radiologist will be informed of some standardized clinical and paraclinical parameters (e.g. fever, CRP, flank pain, relevant comorbidity), but will be blinded to the results of the other imaging investigations.
Sensitivity and specificity of point-of-care ultrasound on identifying hydronephrosis compared to MRI
Time frame: Within 48 hours
How many of hydronephroses in patients suspected of APN is discovered by point of care US performed by an investigator with basic point of care US skills? MRI of the kidneys conducted maximum 24 hours after the point of care US is used as reference standard.
1 secondary outcome
Proportion of patients with APN and hydronephrosis
Time frame: Within 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2022.
- Background: PubMed 30834993Claeys KC, Blanco N, Morgan DJ, Leekha S, Sullivan KV. Advances and Challenges in the Diagnosis and Treatment of Urinary Tract Infections: the Need for Diagnostic Stewardship. Curr Infect Dis Rep. 2019 Mar 5;21(4):11. doi: 10.1007/s11908-019-0668-7.
- Background: PubMed 24443116Rathod SB, Kumbhar SS, Nanivadekar A, Aman K. Role of diffusion-weighted MRI in acute pyelonephritis: a prospective study. Acta Radiol. 2015 Feb;56(2):244-9. doi: 10.1177/0284185114520862. Epub 2014 Jan 17.
- Background: PubMed 30466913Cruz J, Figueiredo F, Matos AP, Duarte S, Guerra A, Ramalho M. Infectious and Inflammatory Diseases of the Urinary Tract: Role of MR Imaging. Magn Reson Imaging Clin N Am. 2019 Feb;27(1):59-75. doi: 10.1016/j.mric.2018.09.001. Epub 2018 Oct 29.
- Background: PubMed 30169495Quaia E, Correas JM, Mehta M, Murchison JT, Gennari AG, van Beek EJR. Gray Scale Ultrasound, Color Doppler Ultrasound, and Contrast-Enhanced Ultrasound in Renal Parenchymal Diseases. Ultrasound Q. 2018 Dec;34(4):250-267. doi: 10.1097/RUQ.0000000000000383.
- Background: PubMed 17941932Mitterberger M, Pinggera GM, Colleselli D, Bartsch G, Strasser H, Steppan I, Pallwein L, Friedrich A, Gradl J, Frauscher F. Acute pyelonephritis: comparison of diagnosis with computed tomography and contrast-enhanced ultrasonography. BJU Int. 2008 Feb;101(3):341-4. doi: 10.1111/j.1464-410X.2007.07280.x. Epub 2007 Oct 17.
- Background: PubMed 28856401Kazmierski B, Deurdulian C, Tchelepi H, Grant EG. Applications of contrast-enhanced ultrasound in the kidney. Abdom Radiol (NY). 2018 Apr;43(4):880-898. doi: 10.1007/s00261-017-1307-0.
- Derived from this study: PubMed 34593497Skjot-Arkil H, Heltborg A, Lorentzen MH, Cartuliares MB, Hertz MA, Graumann O, Rosenvinge FS, Petersen ERB, Ostergaard C, Laursen CB, Skovsted TA, Posth S, Chen M, Mogensen CB. Improved diagnostics of infectious diseases in emergency departments: a protocol of a multifaceted multicentre diagnostic study. BMJ Open. 2021 Sep 30;11(9):e049606. doi: 10.1136/bmjopen-2021-049606.
- 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.
Christian Backer Mogensen study chair
Institute for Regional Health Research
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 Pyelonephritis Acute, run by University of Southern Denmark at 1 site in Denmark.
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 2 inclusion and 7 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: finished, as of the sponsor's last update on 16 Sep 2022. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of inflammatory changes in the kidneys on CEUS compared to MRI (time frame: Routine descriptions of the scans will be available within about 48 hours from recruitment. Focused descriptions and comparison are conducted within 6 months after investigation.). The study lists 3 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 NCT04651244, which also lists 7 linked publications.
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 16 Sep 2022.