- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04686318
Accuracy of Infection Biomarkers in the Investigation of Patients With Suspected Acute Pyelonephritis
What is the Diagnostic and Prognostic Accuracy of C-reactive Protein, Serum Procalcitonin and Soluble Urokinase Plasminogen Activator Receptor in the Initial Investigation of Patients With Suspected Acute Pyelonephritis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Acute pyelonephritis (APN) is a severe acute infection in the upper urinary tract, which quite frequently is seen in the emergency department (ED). In our study, we define APN as a urinary tract infection with extension above the bladder, implicated by systemic affection in a suspected urinary tract infection (ie, fever, chills, malaise and/or lethargy beyond normal, signs of sepsis). Most often, an infection of the bladder ascends to the kidneys, causing APN. Symptoms and clinical affection range from mild to severe, but it is always important to recognize and treat APN fast in order to prevent progression to sepsis, renal failure and ultimately death. Uncertain or delayed diagnosis will often lead to an overconsumption of broad-spectrum antibiotics, which contributes to increased development of resistant bacteria and thus threaten the treatment options of the future.
APN diagnosis is primarily made today on the basis of clinical symptoms and findings in the form of flank tenderness, fever and nausea/vomiting. Typical symptoms of cystitis (dysuria, pollakisuria, suprapubic pain, hematuria) are possible but often absent. Especially elderly can present with more generalized signs of infection with nothing clearly indicating localization to the urinary tract. A positive urine culture verifies the diagnosis, but it is only available after a minimum of 24 hours.
To support the diagnosis of an APN and assess its severity, a measure of the systemic inflammatory response is useful such as abnormal temperature, elevated leucocyte count with neutrocytosis, or elevated C-reactive protein (CRP). Some uncertainty is associated with CRP because it has a delayed response to bacterial infection and is often elevated in non-infectious inflammatory conditions. A more sensitive and specific marker is desired that can differentiate between bacterial and viral infection and reflect the severity of the APN. Serum procalcitonin (PCT) has potential as a diagnostic tool in suspected bacterial infections and can distinguish between viral and bacterial urinary infections. Soluble urokinase plasminogen activator receptor (SuPAR) might have a potential as a marker for acute bacterial infections requiring antibiotic treatment. However, there are no well-conducted studies which compare simultaneously all three biomarkers diagnostic abilities for bacterial infections in general or in relation to APN.
The investigators hypothesize that serum CRP, PTC and suPAR have an impact on diagnosing, prognosis, and treatment of patients with a verified APN.
The objectives of the study are:
- To investigate the diagnostic value of CRP, PCT and suPAR in the diagnosis of APN
- To identify the prognostic value of CRP, PCT and suPAR in relation to adverse events in patients with verified APN
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Aabenraa, Denmark
- Hospital of Southern Jutland
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Suspicion of APN assessed by the receiving physician at the ED
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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suspected acute pyelonephritis
All patients admitted to the emergency department with suspected acute pyelonephritis assessed by the receiving physician
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Blood samples will be collected by a medical laboratory technologist and transferred to the local laboratory for analysis of CRP, PCT and suPAR. Laboratory staff will be blinded to participant diagnosis and outcome. CRP and PCT results will be available to the treating physician, but the suPAR result will not be available.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Verified and non verified acute pyelonephritis (APN)
Time Frame: 2 months after patient discharge
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The decision of whether patients admitted with suspicion of APN actually has a final diagnosis of APN is based on a combination of all findings during admission.
The verification of diagnosis requires human handling, interpretation and judgment.
Therefore, in this study, an expert panel will define the reference standard for the diagnosis APN.
The expert panel consists of two independent consultants from the emergency department with significant experience in emergency medicine and acute infections.
They will individually determine whether or not the patient admitted suspected with APN actually had this diagnosis.
The final diagnosis will be based on all available relevant information from the patient medical record including MRI of the kidneys.
A standardized template will be used.
Disagreement will be discussed until a consensus is reached.
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2 months after patient discharge
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The number of participants who died within 30 days
Time Frame: within 30 days from arrival day
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binary - 30-days mortality
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within 30 days from arrival day
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Readmission
Time Frame: within 30 days from day of discharge
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binary
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within 30 days from day of discharge
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Intensive care unit treatment
Time Frame: within 60 days from admission to the emergency department
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transfer to ICU during current admission (binary outcome)
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within 60 days from admission to the emergency department
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Length of stay
Time Frame: within 60 days from current admission to the emergency department
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days spent in hospital during current admission
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within 60 days from current admission to the emergency department
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In-hospital mortality
Time Frame: within 60 days from admission to the emergency department
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binary
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within 60 days from admission to the emergency department
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The number of participants who died within 90 days
Time Frame: within 90 days from arrival to emergency department
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binary - 90 days mortality
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within 90 days from arrival to emergency department
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bacteriuria
Time Frame: urine collected within 4 hours of arrival to the emergency department
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Binary outcome defined by microbiologist on urine culture analysis
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urine collected within 4 hours of arrival to the emergency department
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Skjot-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.
- Hamie L, Daoud G, Nemer G, Nammour T, El Chediak A, Uthman IW, Kibbi AG, Eid A, Kurban M. SuPAR, an emerging biomarker in kidney and inflammatory diseases. Postgrad Med J. 2018 Sep;94(1115):517-524. doi: 10.1136/postgradmedj-2018-135839. Epub 2018 Sep 3.
- Schuetz P, Christ-Crain M, Muller B. Procalcitonin and other biomarkers to improve assessment and antibiotic stewardship in infections--hope for hype? Swiss Med Wkly. 2009 Jun 13;139(23-24):318-26. doi: 10.4414/smw.2009.12584.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHS-ED-12c-2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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