Pneumonia, BacterialNCT04652167
Diagnostic Accuracy of Infection Biomarkers in the Initial Investigation of Patients With Suspected Pneumonia
An observational study of Pneumonia, Bacterial, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
The aim of this study is to investigate the diagnostic and prognostic value of C-reactive protein (CRP), serum procalcitonin (PCT) and soluble urokinase plasminogen activator receptor (suPAR) in the initial investigation of patients acute hospitalized with suspected community-acquired-pneumonia (CAP) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Bacterial
- What is being tested?
- PCT and suPAR
- Type of treatment
- Injection or infusion
- How many people
- 411 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: Patients admitted at the emergency department with suspected pneumonia by the attending physician.
Who may be able to join
- Adult patients ≥ 18 years old
- Patients suspected with pneumonia by the attending physician. The physician will base his/her suspicion on e.g. clinical symptoms such as cough, increased sputum production, chest tightness, dyspnea and fever > 38⁰C, and indication for chest x-ray
Who cannot join
- 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: 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 Community-acquired Pneumonia
The aim of this study is to investigate the diagnostic and prognostic value of C-reactive protein (CRP), serum procalcitonin (PCT) and soluble urokinase plasminogen activator receptor (suPAR) in the initial investigation of patients acute hospitalized with suspected community-acquired-pneumonia (CAP)
Read the detailed description
Target pneumonia treatment should be initiated within a few hours, which is why early and accurate diagnosis is extremely important. 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. Pneumonia diagnosis is primarily made today on the basis of clinical symptoms and findings in the form of cough, vomiting, chest pain, fever, shortness of breath, supplemented with X-ray of the lungs, relevant blood tests and analysis of expectoration. However, X-ray is an imprecise diagnostic tool. The diagnosis of CAP is challenged by nonspecific symptoms, uncertain diagnostic methods and waiting time for test results up to several days.
Therefore, numerous studies have investigated biomarkers that can possibly support the diagnosis of CAP. C-reactive protein (CRP) and serum procalcitonin (PCT) are biomarkers that may distinguish CAP from other causes of acute respiratory infections. The CRP biomarker has been endorsed as a guide for antibiotic treatment by the National Institute for Health and Care Excellence (NICE) and PCT was suggested by the American Infectious Diseases Society of America. Soluble urokinase plasminogen activator receptor (suPAR) has emerged as a potentially novel biomarker for inflammatory diseases including pneumonia. Several studies have highlighted suPAR as a significant prognostic mortality marker and strongly related to disease severity and worse outcome in a variety of conditions. It is also a promising biological marker in the diagnosis of CAP.
The diagnostic value of the optimal biomarkers for the diagnosis of CAP remains controversial. The investigators hypothesize that serum CRP, PTC and suPAR have an impact on diagnosing, prognosis, and treatment of patients with a verified community-acquired-pneumonia. The objectives of the study are:
- To identify the diagnostic accuracy of CRP, PCT and suPAR in community-acquired pneumonia
- To identify the prognostic value of CRP, PCT and suPAR in relation to adverse events
- Conditions
- Pneumonia, Bacterial
- Being tested
- PCT, suPAR, Standard care
- Keywords
- C-reactive protein,, serum procalcitonin,, soluble urokinase plasminogen activator receptor
- Medical subject headings
- Pneumonia, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCTDiagnostic test
Serum PCT concentration is quantified with an automated sandwich immunoassay "ECLIA" (Elecsys®, BRAHMS PCT-analyses) on Cobas e801. Calibration (BRAHMS PCT LIA assay) is performed once per reagent lot and no later than 24 h after Cobas e pack has been registered in the instrument. Quality control is performed after each calibration.
suPARDiagnostic test
Serum suPAR was measured using suPARnostic© Turbilatex assay reagents (validated on Cobas© c111) protocol for Cobas© c702 and c502 applying the Multi-Pack cassettes (Roche Diagnostics, Mannheim, Germany). Calibration is performed at least once a month or in connection to a new batch of TurbiLatex reagents, after calibration a quality control is performed.
Standard careDiagnostic test
Standard care is the measurement of CRP (C-reactive protein) will be measured with C - reactive protein (CRP4) immunoturbidimetric assay (Tina-quant®, Roche) on Roche/Hitachi cobas© systems c701/702. Calibration is performed (Tina-quant® C - reactive protein IV) once per reagent lot and after 6 months using the same reagent lot. Quality control is required after calibration and according manufacturing instructions.
| Study group | Role | What they receive |
|---|---|---|
| Patients suspected of community-acquired pneumonia | All patients admitted to the emergency department with suspected community- acquired pneumonia by the attending physician Receives: Diagnostic Test: PCT; Diagnostic Test: suPAR; Diagnostic Test: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic of community acquired pneumonia
The percentage of patients diagnosed with community-acquired pneumonia determined by an expert panel. This outcome measure is a binary variable - verified pneumonia or no pneumonia.
The expert panel consists of two independent consultants from the emergency department with experience in infection and emergency medicine, who individually will determine whether the patient admitted with suspected community-acquired pneumonia, had the diagnosis. The diagnosis will be based on all available relevant information from the patient medical record within 48 hours from admission including computed tomography. A standardized template will be used. Disagreement will be discussed until a consensus is reached.
.
Measured: expert assessment within 3 months after patient discharge from the hospital
Secondary outcomes (6)
Intensive care unit (ICU) treatment
Transfer to the intensive care unit will be recorded during the current hospitalization as a binary variable (transferred/not-transferred)
Measured: within 60 days from admission to the emergency department
Length of hospital stay (LOS
Defined as the time (in days) spent in hospital during the current admission. Measured in days from admission to hospital discharge. Discharge date minus admission date.
Measured: within 60 days from current admission to the emergency department
30-days mortality
Mortality within 30 days from admission to the Emergency Department
Measured: 30 days from the admission to the emergency department
90-days mortality
Mortality within 90 days from admission to the Emergency Department
Measured: 90 days from the admission to the emergency department
Readmission
If a subject is admitted over a 30 day period after the current hospitalization discharge measured as a binary outcome Re-admissions/not re-admissions
Measured: within 30 days from the discharge to the hospital
In-hospital mortality
Patient mortality during the current hospitalization. Binary outcome - Died/ Not died
Measured: within 60 days from admission to the emergency department
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 (8)Papers the sponsor has linked to this study.
- Other trials for Pneumonia, BacterialStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- 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
- 411 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, Esbjerg Hospital - University Hospital of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04652167
- Sponsor's protocol ID
- SHS-ED-11d-2020
- Status last verified
- Sep 2022
- First submitted
- 26 Nov 2020
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Johnstone J, Mandell L. Guidelines and quality measures: do they improve outcomes of patients with community-acquired pneumonia? Infect Dis Clin North Am. 2013 Mar;27(1):71-86. doi: 10.1016/j.idc.2012.11.001.
PubMed 23398866Musher DM, Thorner AR. Community-acquired pneumonia. N Engl J Med. 2014 Oct 23;371(17):1619-28. doi: 10.1056/NEJMra1312885. No abstract available.
PubMed 25337751Hey J, Thompson-Leduc P, Kirson NY, Zimmer L, Wilkins D, Rice B, Iankova I, Krause A, Schonfeld SA, DeBrase CR, Bozzette S, Schuetz P. Procalcitonin guidance in patients with lower respiratory tract infections: a systematic review and meta-analysis. Clin Chem Lab Med. 2018 Jul 26;56(8):1200-1209. doi: 10.1515/cclm-2018-0126.
PubMed 29715176Wussler D, Kozhuharov N, Tavares Oliveira M, Bossa A, Sabti Z, Nowak A, Murray K, du Fay de Lavallaz J, Badertscher P, Twerenbold R, Shrestha S, Flores D, Nestelberger T, Walter J, Boeddinghaus J, Zimmermann T, Koechlin L, von Eckardstein A, Breidthardt T, Mueller C. Clinical Utility of Procalcitonin in the Diagnosis of Pneumonia. Clin Chem. 2019 Dec;65(12):1532-1542. doi: 10.1373/clinchem.2019.306787. Epub 2019 Oct 15.
PubMed 31615771Loonen AJM, Kesarsing C, Kusters R, Hilbink M, Wever PC, van den Brule AJC. High pneumococcal DNA load, procalcitonin and suPAR levels correlate to severe disease development in patients with pneumococcal pneumonia. Eur J Clin Microbiol Infect Dis. 2017 Sep;36(9):1541-1547. doi: 10.1007/s10096-017-2963-2. Epub 2017 Mar 29.
PubMed 28353184Ni W, Han Y, Zhao J, Cui J, Wang K, Wang R, Liu Y. Serum soluble urokinase-type plasminogen activator receptor as a biological marker of bacterial infection in adults: a systematic review and meta-analysis. Sci Rep. 2016 Dec 19;6:39481. doi: 10.1038/srep39481.
PubMed 27991579Song S, Jia Q, Chen X, Lei Z, He X, Leng Z, Chen S. Serum suPAR associated with disease severity and mortality in elderly patients with community-acquired pneumonia. Scand J Clin Lab Invest. 2020 Oct;80(6):515-522. doi: 10.1080/00365513.2020.1795920. Epub 2020 Jul 27.
PubMed 32716662Skjot-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 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 Community-acquired Pneumonia
- ClinicalTrials.gov ID
- NCT04652167
- Acronym / sponsor ID
- SHS-ED-11d-2020
- Conditions
- Pneumonia, Bacterial
- Keywords
- C-reactive protein,, serum procalcitonin,, soluble urokinase plasminogen activator receptor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 411 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.
The aim of this study is to investigate the diagnostic and prognostic value of C-reactive protein (CRP), serum procalcitonin (PCT) and soluble urokinase plasminogen activator receptor (suPAR) in the initial investigation of patients acute hospitalized with suspected community-acquired-pneumonia (CAP)
Detailed description
Target pneumonia treatment should be initiated within a few hours, which is why early and accurate diagnosis is extremely important. 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. Pneumonia diagnosis is primarily made today on the basis of clinical symptoms and findings in the form of cough, vomiting, chest pain, fever, shortness of breath, supplemented with X-ray of the lungs, relevant blood tests and analysis of expectoration. However, X-ray is an imprecise diagnostic tool. The diagnosis of CAP is challenged by nonspecific symptoms, uncertain diagnostic methods and waiting time for test results up to several days.
Therefore, numerous studies have investigated biomarkers that can possibly support the diagnosis of CAP. C-reactive protein (CRP) and serum procalcitonin (PCT) are biomarkers that may distinguish CAP from other causes of acute respiratory infections. The CRP biomarker has been endorsed as a guide for antibiotic treatment by the National Institute for Health and Care Excellence (NICE) and PCT was suggested by the American Infectious Diseases Society of America. Soluble urokinase plasminogen activator receptor (suPAR) has emerged as a potentially novel biomarker for inflammatory diseases including pneumonia. Several studies have highlighted suPAR as a significant prognostic mortality marker and strongly related to disease severity and worse outcome in a variety of conditions. It is also a promising biological marker in the diagnosis of CAP.
The diagnostic value of the optimal biomarkers for the diagnosis of CAP remains controversial. The investigators hypothesize that serum CRP, PTC and suPAR have an impact on diagnosing, prognosis, and treatment of patients with a verified community-acquired-pneumonia. The objectives of the study are:
- To identify the diagnostic accuracy of CRP, PCT and suPAR in community-acquired pneumonia
- To identify the prognostic value of CRP, PCT and suPAR in relation to adverse events
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients suspected of community-acquired pneumonia | – | Diagnostic Test: PCT, Diagnostic Test: suPAR, Diagnostic Test: Standard careAll patients admitted to the emergency department with suspected community- acquired pneumonia by the attending physician |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted at the emergency department with suspected pneumonia by the attending physician.
Key inclusion criteria (2 listed)
- Adult patients ≥ 18 years old
- Patients suspected with pneumonia by the attending physician. The physician will base his/her suspicion on e.g. clinical symptoms such as cough, increased sputum production, chest tightness, dyspnea and fever > 38⁰C, and indication for chest x-ray
Key exclusion criteria (5 listed)
- 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)
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 |
|---|---|---|
| PCTSerum PCT concentration is quantified with an automated sandwich immunoassay "ECLIA" (Elecsys®, BRAHMS PCT-analyses) on Cobas e801. Calibration (BRAHMS PCT LIA assay) is performed once per reagent lot and no later than 24 h after Cobas e pack has been registered in the instrument. Quality control is performed after each calibration. | Diagnostic test | Patients suspected of community-acquired pneumonia |
| suPARSerum suPAR was measured using suPARnostic© Turbilatex assay reagents (validated on Cobas© c111) protocol for Cobas© c702 and c502 applying the Multi-Pack cassettes (Roche Diagnostics, Mannheim, Germany). Calibration is performed at least once a month or in connection to a new batch of TurbiLatex reagents, after calibration a quality control is performed. | Diagnostic test | Patients suspected of community-acquired pneumonia |
| Standard careStandard care is the measurement of CRP (C-reactive protein) will be measured with C - reactive protein (CRP4) immunoturbidimetric assay (Tina-quant®, Roche) on Roche/Hitachi cobas© systems c701/702. Calibration is performed (Tina-quant® C - reactive protein IV) once per reagent lot and after 6 months using the same reagent lot. Quality control is required after calibration and according manufacturing instructions. | Diagnostic test | Patients suspected of community-acquired pneumonia |
Primary outcome
Diagnostic of community acquired pneumonia
Time frame: expert assessment within 3 months after patient discharge from the hospital
The percentage of patients diagnosed with community-acquired pneumonia determined by an expert panel. This outcome measure is a binary variable - verified pneumonia or no pneumonia. The expert panel consists of two independent consultants from the emergency department with experience in infection and emergency medicine, who individually will determine whether the patient admitted with suspected community-acquired pneumonia, had the diagnosis. The diagnosis will be based on all available relevant information from the patient medical record within 48 hours from admission including computed tomography. A standardized template will be used. Disagreement will be discussed until a consensus is reached. .
6 secondary outcomes
Intensive care unit (ICU) treatment
Time frame: within 60 days from admission to the emergency department
Length of hospital stay (LOS
Time frame: within 60 days from current admission to the emergency department
30-days mortality
Time frame: 30 days from the admission to the emergency department
90-days mortality
Time frame: 90 days from the admission to the emergency department
Readmission
Time frame: within 30 days from the discharge to the hospital
In-hospital mortality
Time frame: within 60 days from admission to the emergency department
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 14 Sep 2022.
- Background: PubMed 23398866Johnstone J, Mandell L. Guidelines and quality measures: do they improve outcomes of patients with community-acquired pneumonia? Infect Dis Clin North Am. 2013 Mar;27(1):71-86. doi: 10.1016/j.idc.2012.11.001.
- Background: PubMed 25337751Musher DM, Thorner AR. Community-acquired pneumonia. N Engl J Med. 2014 Oct 23;371(17):1619-28. doi: 10.1056/NEJMra1312885. No abstract available.
- Background: PubMed 29715176Hey J, Thompson-Leduc P, Kirson NY, Zimmer L, Wilkins D, Rice B, Iankova I, Krause A, Schonfeld SA, DeBrase CR, Bozzette S, Schuetz P. Procalcitonin guidance in patients with lower respiratory tract infections: a systematic review and meta-analysis. Clin Chem Lab Med. 2018 Jul 26;56(8):1200-1209. doi: 10.1515/cclm-2018-0126.
- Background: PubMed 31615771Wussler D, Kozhuharov N, Tavares Oliveira M, Bossa A, Sabti Z, Nowak A, Murray K, du Fay de Lavallaz J, Badertscher P, Twerenbold R, Shrestha S, Flores D, Nestelberger T, Walter J, Boeddinghaus J, Zimmermann T, Koechlin L, von Eckardstein A, Breidthardt T, Mueller C. Clinical Utility of Procalcitonin in the Diagnosis of Pneumonia. Clin Chem. 2019 Dec;65(12):1532-1542. doi: 10.1373/clinchem.2019.306787. Epub 2019 Oct 15.
- Background: PubMed 28353184Loonen AJM, Kesarsing C, Kusters R, Hilbink M, Wever PC, van den Brule AJC. High pneumococcal DNA load, procalcitonin and suPAR levels correlate to severe disease development in patients with pneumococcal pneumonia. Eur J Clin Microbiol Infect Dis. 2017 Sep;36(9):1541-1547. doi: 10.1007/s10096-017-2963-2. Epub 2017 Mar 29.
- Background: PubMed 27991579Ni W, Han Y, Zhao J, Cui J, Wang K, Wang R, Liu Y. Serum soluble urokinase-type plasminogen activator receptor as a biological marker of bacterial infection in adults: a systematic review and meta-analysis. Sci Rep. 2016 Dec 19;6:39481. doi: 10.1038/srep39481.
- Background: PubMed 32716662Song S, Jia Q, Chen X, Lei Z, He X, Leng Z, Chen S. Serum suPAR associated with disease severity and mortality in elderly patients with community-acquired pneumonia. Scand J Clin Lab Invest. 2020 Oct;80(6):515-522. doi: 10.1080/00365513.2020.1795920. Epub 2020 Jul 27.
- 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
Esbjerg Hospital - University Hospital of Southern Denmark
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 Pneumonia, Bacterial, 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 5 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 14 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?
Diagnostic of community acquired pneumonia (time frame: expert assessment within 3 months after patient discharge from the hospital). 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 NCT04652167, which also lists 8 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 14 Sep 2022.