SepsisPhase 2/3NCT03717350
suPAR to Guide Antibiotics in Emergency Department
A Phase 2/3 study testing Meropenem in people with Sepsis, run by Hellenic Institute for the Study of Sepsis at 5 sites in Greece.
Trial summary
The aim of the current study is to evaluate suPAR - guided medical intervention, consisting of early antibiotic administration at the emergency room for presumed infection and sepsis and evaluate the impact of this intervention to the patients' final outcome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Meropenem
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 5 sitesGreece
- Study dates
- 27 Oct 2018to 31 Aug 2021
- Phase
- Phase 2/3
- 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
Who may be able to join
- Written informed consent provided by the patient or by their legal representative in case of patients unable to consent
- Age equal to or above 18 years
- Male or female gender
- Clinical suspicion of infection
- qSOFA equal to 1 point
- suPAR blood level equal or above 12 ng/ml
Who cannot join
- Denial to consent
- Patients with 2 or 3 qSOFA signs
- Pregnancy (confirmed by blood or urinary pregnancy test) for female patients of reproductive age
- Organ transplantation
- Fully-blown sepsis with overt failing organs necessitating immediate resuscitation as defined by the attending physicians
- Do not resuscitate decision
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Greece5 sites, 5 recruiting
- Recruiting
4th Department of Internal Medicine, ATTIKON University Hospital
Athens, Attica, 12462
Antonios Papadopoulos, MD, PhD, +306977302400, antpapa1@otenet.gr
Evdoxia Kyriazopoulou, MD, PhD, +302105832563, ekyr@med.uoa.gr
- Recruiting
1st Department of Internal Medicine of G. GENNIMATAS General Hospital
Athens, 11527
George Adamis, MD, 2107768534, adamismd@otenet.gr
- Recruiting
3rd Department of Internal Medicine at SOTIRIA General Hospital of Chest Diseases of Athens
Athens, 11527
Garyfallia Poulakou, MD, PhD, 2107763400, gpoulakou@gmail.com
- Recruiting
Εmergency Department of Sismanogleion Athens General Hospital
Athens, 15126
Vassileios Kaldis, MD, 2132058 841, vkaldis@yahoo.gr
- Recruiting
Department of Internal Medicine, Patras University Hospital
Pátrai
Charalambos Gogos, MD, PhD, +306944799784, cgogos@med.upatras.gr
Karolina Akinosoglou, MD, PhD, ++306977762897, akin@upatras.gr
About this study
Official title: A suPAR Guided Double-blind Randomized Clinical Trial of Initiation of Antibiotics for Presumed Infection at the Emergency Department
The aim of the current study is to evaluate suPAR - guided medical intervention, consisting of early antibiotic administration at the emergency room for presumed infection and sepsis and evaluate the impact of this intervention to the patients' final outcome. Since the traditionally used biomarkers (PCT, CRP) and scores (SOFA score) for early recognition of severity of infection fail to achieve maximum accuracy in all cases, suPAR levels are assessed as a probably better prognostic rule for early recognition of severe infections. The primary study endpoint will be the comparative efficacy of the early suPAR-guided administration of antibiotics versus standard practice on 28-day mortality.
Read the detailed description
Sepsis is among the leading causes of death worldwide. It is well-perceived that early recognition of sepsis is the mainstay of treatment. Recently it has been proposed that the quick sequential organ fialure assessment (qSOFA) score can be used as a screening tool in the emergency department (ED) to triage patients with high-risk of death; patients scoring positive at least two of the three signs of qSOFA are at a high-risk for death. However, this is challenged since it may be the case that the risk of death is high even among patients with only one sign of qSOFA.
Soluble urokinase plasminogen activator receptor (suPAR), the soluble form of the membrane bound receptor (uPAR), is a recently known glycoprotein involved in inflammation. uPAR is expressed on various immune cells (neutrophils, lymphocytes, monocytes, macrophages) and is cleaved from their surface after an inflammatory stimuli to enhance chemotaxis and cell migration. Increased suPAR blood levels mirror the degree of activation of the immune system by different antigenic stimuli including diverse neoplastic and infectious agents and other inflammation-mediated diseases. SuPAR levels generally correlate to the severity of the disease.
It has been shown that suPAR blood levels have low diagnostic value (cannot discriminate between bacterial, viral or parasitic infection, Gram (+) or Gram (-) bacteraemia. However, they present superior prognostic value as compared with single parameters of inflammation and organ dysfunction (like C-reactive protein (CRP) and procalcitonin (PCT) in critically ill patients, and suPAR's prognostic value of death is even more enhanced when combined to other biomarkers and physiological scores (e.g. Acute Physiology and Chronic Health Evaluation-APACHE II).
Why choose suPAR as biomarker at emergency basis? Because, in contrast to many pro-inflammatory cytokines, suPAR exhibits favorable properties due to its high stability in serum samples and limited circadian changes in plasma concentrations. It also constitutes a serum/plasma biomarker that is easily performed on-site and provides information within one hour after sampling21, 22.
Unpublished data of the Hellenic Sepsis Study Group (HSSG) suggest that among patients with at least one sign of the qSOFA score, those with suPAR greater than 12 ng/ml are at a substantial risk for death with mortality exceeding 30%. To this end, patients with suspicion for an infection and with qSOFA 1 and suPAR greater than 12 ng/ml constitute a group of patients requiring early intervention.
The aim of the current study is to evaluate suPAR - guided medical intervention, consisting of early antibiotics' administration at the emergency room for presumed infection and sepsis and evaluate the impact of this intervention to the patients' final outcome.
- Conditions
- Sepsis
- Being tested
- Meropenem, Placebo
- Keywords
- biomarkers, suPAR, outcome, antibiotics
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeropenemDrug
Also called Carbapenem
2g of meropenem diluted in 100ml of sodium chloride 0.9% within 15 minutes intravenously administered once
PlaceboDrug
Also called Diluent
100ml of sodium chloride 0.9% within 15 minutes intravenously once
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 100ml of sodium chloride 0.9% within 15 minutes intravenously Receives: Drug: Placebo |
| Antibiotic | Active comparator | 2g of meropenem diluted in 100ml of sodium chloride 0.9% within 15 minutes intravenously Receives: Drug: Meropenem |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy of the applied intervention versus standard practice on the early worsening of the patient.
The primary study endpoint will be the comparative efficacy of the applied intervention (meropenem versus standard practice on the early worsening of the patient. This is defined as any at least one point increase of the admission total SOFA score the first 24 hours.
Measured: 1 day (24 hours)
Secondary outcomes (9)
Sepsis mortality
Comparative efficacy of the applied intervention on mortality for patients meeting the Sepsis-3 definition of sepsis
Measured: 28 days
Short-term mortality
Comparative efficacy of the applied intervention on 7-day mortality
Measured: 7 days
Long-term mortality 1
Comparative efficacy of the applied intervention on 60-day mortality
Measured: 60 days
Long-term mortality 2
Comparative efficacy of the applied intervention on 90-day mortality
Measured: 90 days
Infection resolution
Effect of the intervention on the time to infection resolution. This time point is limited for patients who will eventually be diagnosed of a specific infectious diseases making them eligible for the study and it is defined as the time point when all clinical signs of the infection are cleared.
Measured: 90 days
Change of initial treatment
Comparative efficacy of the applied intervention on the need to change antibiotics
Measured: 28 days
Duration of hospitalization
Comparative efficacy of the applied intervention on the duration of hospitalization
Measured: 90 days
Rate of new infections
Comparative efficacy of the applied intervention on the rate of new infections
Measured: 90 days
The early worsening of the patient
The early worsening of the patient defined as for the primary endpoint but analyzed separately per quartile of the total SOFA score of the patient population
Measured: 1 day (24 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2018
- Study start27 Oct 2018
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hellenic Institute for the Study of Sepsis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Evangelos Giamarellos-Bourboulis, MD, PhD, Study chair, Attikon Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03717350
- Sponsor's protocol ID
- SUPERIOR
- Status last verified
- Jul 2020
- First submitted
- 20 Oct 2018
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Giamarellos-Bourboulis EJ, Tsaganos T, Tsangaris I, Lada M, Routsi C, Sinapidis D, Koupetori M, Bristianou M, Adamis G, Mandragos K, Dalekos GN, Kritselis I, Giannikopoulos G, Koutelidakis I, Pavlaki M, Antoniadou E, Vlachogiannis G, Koulouras V, Prekates A, Dimopoulos G, Koutsoukou A, Pnevmatikos I, Ioakeimidou A, Kotanidou A, Orfanos SE, Armaganidis A, Gogos C; Hellenic Sepsis Study Group. Validation of the new Sepsis-3 definitions: proposal for improvement in early risk identification. Clin Microbiol Infect. 2017 Feb;23(2):104-109. doi: 10.1016/j.cmi.2016.11.003. Epub 2016 Nov 14.
PubMed 27856268Giamarellos-Bourboulis EJ, Norrby-Teglund A, Mylona V, Savva A, Tsangaris I, Dimopoulou I, Mouktaroudi M, Raftogiannis M, Georgitsi M, Linner A, Adamis G, Antonopoulou A, Apostolidou E, Chrisofos M, Katsenos C, Koutelidakis I, Kotzampassi K, Koratzanis G, Koupetori M, Kritselis I, Lymberopoulou K, Mandragos K, Marioli A, Sunden-Cullberg J, Mega A, Prekates A, Routsi C, Gogos C, Treutiger CJ, Armaganidis A, Dimopoulos G. Risk assessment in sepsis: a new prognostication rule by APACHE II score and serum soluble urokinase plasminogen activator receptor. Crit Care. 2012 Aug 8;16(4):R149. doi: 10.1186/cc11463.
PubMed 22873681Adami ME, Kotsaki A, Antonakos N, Giannitsioti E, Chalvatzis S, Saridaki M, Avgoustou C, Akinosoglou K, Dakou K, Damoraki G, Katrini K, Koufargyris P, Lekakis V, Panagaki A, Safarika A, Eugen-Olsen J, Giamarellos-Bourboulis EJ. qSOFA combined with suPAR for early risk detection and guidance of antibiotic treatment in the emergency department: a randomized controlled trial. Crit Care. 2024 Feb 6;28(1):42. doi: 10.1186/s13054-024-04825-2.
PubMed 38321472Kyriazopoulou E, Poulakou G, Giamarellos-Bourboulis EJ. Biomarkers in sepsis: can they help improve patient outcome? Curr Opin Infect Dis. 2021 Apr 1;34(2):126-134. doi: 10.1097/QCO.0000000000000707.
PubMed 33534419
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A suPAR Guided Double-blind Randomized Clinical Trial of Initiation of Antibiotics for Presumed Infection at the Emergency Department
- ClinicalTrials.gov ID
- NCT03717350
- Acronym / sponsor ID
- SUPERIOR
- Conditions
- Sepsis
- Keywords
- biomarkers, suPAR, outcome, antibiotics
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Hellenic Institute for the Study of SepsisUniversity, hospital or other
- Study start
- 27 Oct 2018 (actual)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 24 Oct 2018 (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 the current study is to evaluate suPAR - guided medical intervention, consisting of early antibiotic administration at the emergency room for presumed infection and sepsis and evaluate the impact of this intervention to the patients' final outcome. Since the traditionally used biomarkers (PCT, CRP) and scores (SOFA score) for early recognition of severity of infection fail to achieve maximum accuracy in all cases, suPAR levels are assessed as a probably better prognostic rule for early recognition of severe infections. The primary study endpoint will be the comparative efficacy of the early suPAR-guided administration of antibiotics versus standard practice on 28-day mortality.
Detailed description
Sepsis is among the leading causes of death worldwide. It is well-perceived that early recognition of sepsis is the mainstay of treatment. Recently it has been proposed that the quick sequential organ fialure assessment (qSOFA) score can be used as a screening tool in the emergency department (ED) to triage patients with high-risk of death; patients scoring positive at least two of the three signs of qSOFA are at a high-risk for death. However, this is challenged since it may be the case that the risk of death is high even among patients with only one sign of qSOFA.
Soluble urokinase plasminogen activator receptor (suPAR), the soluble form of the membrane bound receptor (uPAR), is a recently known glycoprotein involved in inflammation. uPAR is expressed on various immune cells (neutrophils, lymphocytes, monocytes, macrophages) and is cleaved from their surface after an inflammatory stimuli to enhance chemotaxis and cell migration. Increased suPAR blood levels mirror the degree of activation of the immune system by different antigenic stimuli including diverse neoplastic and infectious agents and other inflammation-mediated diseases. SuPAR levels generally correlate to the severity of the disease.
It has been shown that suPAR blood levels have low diagnostic value (cannot discriminate between bacterial, viral or parasitic infection, Gram (+) or Gram (-) bacteraemia. However, they present superior prognostic value as compared with single parameters of inflammation and organ dysfunction (like C-reactive protein (CRP) and procalcitonin (PCT) in critically ill patients, and suPAR's prognostic value of death is even more enhanced when combined to other biomarkers and physiological scores (e.g. Acute Physiology and Chronic Health Evaluation-APACHE II).
Why choose suPAR as biomarker at emergency basis? Because, in contrast to many pro-inflammatory cytokines, suPAR exhibits favorable properties due to its high stability in serum samples and limited circadian changes in plasma concentrations. It also constitutes a serum/plasma biomarker that is easily performed on-site and provides information within one hour after sampling21, 22.
Unpublished data of the Hellenic Sepsis Study Group (HSSG) suggest that among patients with at least one sign of the qSOFA score, those with suPAR greater than 12 ng/ml are at a substantial risk for death with mortality exceeding 30%. To this end, patients with suspicion for an infection and with qSOFA 1 and suPAR greater than 12 ng/ml constitute a group of patients requiring early intervention.
The aim of the current study is to evaluate suPAR - guided medical intervention, consisting of early antibiotics' administration at the emergency room for presumed infection and sepsis and evaluate the impact of this intervention to the patients' final outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo100ml of sodium chloride 0.9% within 15 minutes intravenously |
| Antibiotic | Active comparator | Drug: Meropenem2g of meropenem diluted in 100ml of sodium chloride 0.9% within 15 minutes intravenously |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Written informed consent provided by the patient or by their legal representative in case of patients unable to consent
- Age equal to or above 18 years
- Male or female gender
- Clinical suspicion of infection
- qSOFA equal to 1 point
Key exclusion criteria (6 listed)
- Denial to consent
- Patients with 2 or 3 qSOFA signs
- Pregnancy (confirmed by blood or urinary pregnancy test) for female patients of reproductive age
- Organ transplantation
- Fully-blown sepsis with overt failing organs necessitating immediate resuscitation as defined by the attending physicians
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 |
|---|---|---|
| MeropenemAlso: Carbapenem2g of meropenem diluted in 100ml of sodium chloride 0.9% within 15 minutes intravenously administered once | Drug | Antibiotic |
| PlaceboAlso: Diluent100ml of sodium chloride 0.9% within 15 minutes intravenously once | Drug | Placebo |
Primary outcome
The efficacy of the applied intervention versus standard practice on the early worsening of the patient.
Time frame: 1 day (24 hours)
The primary study endpoint will be the comparative efficacy of the applied intervention (meropenem versus standard practice on the early worsening of the patient. This is defined as any at least one point increase of the admission total SOFA score the first 24 hours.
9 secondary outcomes
Sepsis mortality
Time frame: 28 days
Short-term mortality
Time frame: 7 days
Long-term mortality 1
Time frame: 60 days
Long-term mortality 2
Time frame: 90 days
Infection resolution
Time frame: 90 days
Change of initial treatment
Time frame: 28 days
Duration of hospitalization
Time frame: 90 days
Rate of new infections
Time frame: 90 days
The early worsening of the patient
Time frame: 1 day (24 hours)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
- Background: PubMed 27856268Giamarellos-Bourboulis EJ, Tsaganos T, Tsangaris I, Lada M, Routsi C, Sinapidis D, Koupetori M, Bristianou M, Adamis G, Mandragos K, Dalekos GN, Kritselis I, Giannikopoulos G, Koutelidakis I, Pavlaki M, Antoniadou E, Vlachogiannis G, Koulouras V, Prekates A, Dimopoulos G, Koutsoukou A, Pnevmatikos I, Ioakeimidou A, Kotanidou A, Orfanos SE, Armaganidis A, Gogos C; Hellenic Sepsis Study Group. Validation of the new Sepsis-3 definitions: proposal for improvement in early risk identification. Clin Microbiol Infect. 2017 Feb;23(2):104-109. doi: 10.1016/j.cmi.2016.11.003. Epub 2016 Nov 14.
- Background: PubMed 22873681Giamarellos-Bourboulis EJ, Norrby-Teglund A, Mylona V, Savva A, Tsangaris I, Dimopoulou I, Mouktaroudi M, Raftogiannis M, Georgitsi M, Linner A, Adamis G, Antonopoulou A, Apostolidou E, Chrisofos M, Katsenos C, Koutelidakis I, Kotzampassi K, Koratzanis G, Koupetori M, Kritselis I, Lymberopoulou K, Mandragos K, Marioli A, Sunden-Cullberg J, Mega A, Prekates A, Routsi C, Gogos C, Treutiger CJ, Armaganidis A, Dimopoulos G. Risk assessment in sepsis: a new prognostication rule by APACHE II score and serum soluble urokinase plasminogen activator receptor. Crit Care. 2012 Aug 8;16(4):R149. doi: 10.1186/cc11463.
- Derived from this study: PubMed 38321472Adami ME, Kotsaki A, Antonakos N, Giannitsioti E, Chalvatzis S, Saridaki M, Avgoustou C, Akinosoglou K, Dakou K, Damoraki G, Katrini K, Koufargyris P, Lekakis V, Panagaki A, Safarika A, Eugen-Olsen J, Giamarellos-Bourboulis EJ. qSOFA combined with suPAR for early risk detection and guidance of antibiotic treatment in the emergency department: a randomized controlled trial. Crit Care. 2024 Feb 6;28(1):42. doi: 10.1186/s13054-024-04825-2.
- Derived from this study: PubMed 33534419Kyriazopoulou E, Poulakou G, Giamarellos-Bourboulis EJ. Biomarkers in sepsis: can they help improve patient outcome? Curr Opin Infect Dis. 2021 Apr 1;34(2):126-134. doi: 10.1097/QCO.0000000000000707.
- 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.
Evangelos Giamarellos-Bourboulis, MD, PhD study chair
Attikon Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Meropenem in people with Sepsis, run by Hellenic Institute for the Study of Sepsis at 5 sites in Greece.
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 6 inclusion and 6 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 30 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Greece. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Evangelos J Giamarellos-Bourboulis, MD, PhD (+306945521800, egiamarel@med.uoa.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The efficacy of the applied intervention versus standard practice on the early worsening of the patient. (time frame: 1 day (24 hours)). 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 NCT03717350, which also lists 4 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 30 Jul 2020.