4th Department of Internal Medicine, ATTIKON University Hospital
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 22 Trials 
40 Trials

   

 
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Giamarellos-Bourboulis, Evangelos J
ACCESS, NCT04724044: Anti-inflammatory Action of Oral Clarithromycin in Community-acquired Pneumonia

Completed
3
278
Europe
Tablets, 2g of intravenous ceftriaxone or one β-lactam/β-lactamase combination(dose adjusted according to renal clearance) or 400mg of intravenous moxifloxacin, Clarithromycin 500mg
Hellenic Institute for the Study of Sepsis
Community-acquired Pneumonia, Sepsis, Inflammatory Response, Mortality, Biomarkers, SIRS
04/23
04/23
REACT, NCT06294600: Clarithromycin Treatment to Prevent Sepsis Progression in CAP

Recruiting
3
330
Europe
Clarithromycin 500mg, A β-lactam/β-lactamase inhibitor or a 3rd generation cephalosporin or a fluoroquinolone, Tablets
Hellenic Institute for the Study of Sepsis
Community-acquired Pneumonia
11/25
01/26
MODIFY, NCT05909683: Assessing the Procalcitonin-guidance and Molecular-guided Diagnosis for Therapy of Severe Infections (the Trial)

Recruiting
3
190
Europe
Change of antimicrobials based on BCID2 and Reveal Rapid AST tests. Stop of antimicrobials based on PCT results., Standard of Care
Hellenic Institute for the Study of Sepsis
Sepsis
07/25
07/25
PRECISION, NCT05926505 / 2023-000102-25: Safety and Efficacy of Anakinra Treatment for Patients With Post Acute Covid Syndrome

Recruiting
2/3
182
Europe
Placebo, Anakinra 149 MG/ML Prefilled Syringe [Kineret]
Hellenic Institute for the Study of Sepsis, Hellenic Institute for the Study of Sepsis
Post-Acute COVID-19 Syndrome, Post-Acute COVID-19, Long COVID
08/25
08/25
NCT05279352 / 2021-002390-25: Safety and Pharmacokinetics of FBR-002 for the Treatment of Patients Hospitalized With COVID-19 in Need of Supplemental Oxygen and at Risk of Severe Outcome

Recruiting
2a
30
Europe
FBR-002, Placebo
Fab'entech, European Commission (Hera incubator - EPIC Crown-2 project)
COVID-19
06/22
07/22
BEYOND, NCT05304715 / 2021-005473-10: Bezlotoxumab Yielded Outcomes by Addressing Personalized Needs in Clostridioides Difficile Infection

Completed
2
44
Europe
Bezlotoxumab, Standard-of-care treatment according to local guidelines or to the decision of the attending physicians., Normal saline 0.9% or 5% dextrose water, Standard-of-care treatment according to local guidelines or to the decision of the attending physicians
Hellenic Institute for the Study of Sepsis
Clostridioides Difficile Infection, Stool Microbiome, Organ Dysfunction Syndrome, Clostridioides Difficile Infection Recurrence, Mortality
06/23
06/23
NCT04979052: Safety and Efficacy of Interferon-Gamma 1b in Patients With Candidemia

Recruiting
2
200
Europe, US
Interferon Gamma-1B, Immukin
Radboud University Medical Center, Horizon 2020 - European Commission
Candidemia
06/26
06/26
INSPIRE, NCT05785442: Use of Presepsin as a Marker for Immunotherapy Administration in Pneumonia

Completed
2
60
Europe
Anakinra Prefilled Syringe, Kineret, Placebo, NaCl
Hellenic Institute for the Study of Sepsis
Community-acquired Pneumonia, Hospital-acquired Pneumonia
06/24
06/24
NCT06694701: Emapalumab Treatment for Anticipated Clinical Benefit in Sepsis Driven by the Interferon-Gamma Endotype (The EMBRACE Trial)

Recruiting
2
75
Europe
Emapalumab-Izsg, Emapalumab Group 1, Emapalumab Group 2, Placebo
Hellenic Institute for the Study of Sepsis
Sepsis
11/26
11/26
NCT04063332: Functionality of Endogenous Biological Clock in Sepsis

Recruiting
N/A
60
Europe
University of Athens, Hellenic Sepsis Study Group
Circadian Rhythm Disorders, Sepsis
06/24
06/24
NCT05059808: European Sepsis Care Survey

Completed
N/A
1450
Europe, RoW
University Medicine Greifswald, European Sepsis Alliance, European Society of Anaesthesiology and Intensive Care, European Society for Emergency Medicine (EUSEM) Research Network, European Society of Clinical Microbiology and Infectious Diseases, ESGBIES Study Group, European Society of Intensive Care Medicine, Sepsisdialog, Germany, European Shock Society, Becton, Dickinson and Company
Sepsis
04/22
10/22
BEYOND, NCT04725123: Addressing Personalized Needs in Clostridioides Difficile Infection

Completed
N/A
153
Europe
Microbiome analysis
Hellenic Institute for the Study of Sepsis
Clostridioides Difficile Infection
03/22
03/22
SEPSIS-SHIELD, NCT04094818: TriVerity in the Diagnosis and Prognosis of Emergency Department Patients With Suspected Infections and Suspected Sepsis

Completed
N/A
1441
Europe, US
TriVerity, InSep, HostDx Sepsis
Inflammatix
Respiratory Tract Infections, Urinary Tract Infections, Intra-Abdominal Infections, Skin and Soft Tissue Infection, Suspected Meningitis/Encephalitis or Any Other Infection, Sepsis
08/24
09/24
CRONUS, NCT05897801: Distinguishing Bacterial and Viral Infections by MeMed BV® Test to Limit Gut Colonization by MDRO

Completed
N/A
230
Europe
MeMed BV®
Hellenic Institute for the Study of Sepsis
Viral Infection, Bacterial Infections, Multi-antibiotic Resistance, Respiratory Tract Infections
12/23
01/24
BIOARTE, NCT06141395: NGS-Based Assay of Blood Samples of Sepsis Patients for Rapid Bacterial Identification

Completed
N/A
100
Europe
NGS-based assay for bacterial identification
Hellenic Institute for the Study of Sepsis, The BioArte
Pneumonia, Acute Pyelonephritis, Bacteremia, Biliary Tract Infection
03/24
03/24
HOMI-LUNG CAP, NCT06601998: Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19.

Recruiting
N/A
650
Europe
Blood samples and Oropharyngeal swab, Six-minute walk test, Spirometry, ECG, Heart ultrasound and cardiopulmonary exercise stress testing, Completion of questionnaires of symptoms
Hellenic Institute for the Study of Sepsis
Pneumonia, Community-Acquired, COVID-19 Pneumonia, Cardiovascular Diseases
11/27
11/27
POINT, NCT06608849: The Incidence of Pulmonary, Cardiovascular and Renal System Non-communicable Complications Associated with the Post-acute Phase of the Infection by Covid-19

Recruiting
N/A
345
Europe
Blood samples, Six-minute walk test, Spirometry, HRCT, Heart ultrasound, Completion of questionnaires of symptoms
Hellenic Institute for the Study of Sepsis
Pulmonary Complications, Cardiovascular Complications, Renal Complications, COVID-19
11/27
11/27
PROACT, NCT06092554: Probiotics to Actively Counter Ventilator Associated Pneumonia

Recruiting
N/A
186
Europe
LactoLevure, Placebo
University of Bari, Uni-Pharma
Ventilator Associated Pneumonia
05/25
05/25
Papadopoulos, Antonios
REACT, NCT06294600: Clarithromycin Treatment to Prevent Sepsis Progression in CAP

Recruiting
3
330
Europe
Clarithromycin 500mg, A β-lactam/β-lactamase inhibitor or a 3rd generation cephalosporin or a fluoroquinolone, Tablets
Hellenic Institute for the Study of Sepsis
Community-acquired Pneumonia
11/25
01/26
ImmunoSep, NCT04990232 / 2020-005768-74: Personalized Immunotherapy in Sepsis

Completed
2
280
Europe
Anakinra or rhIFNγ, Imukin, Kineret, Placebo
Hellenic Institute for the Study of Sepsis
Sepsis
02/24
04/24
BEYOND, NCT05304715 / 2021-005473-10: Bezlotoxumab Yielded Outcomes by Addressing Personalized Needs in Clostridioides Difficile Infection

Completed
2
44
Europe
Bezlotoxumab, Standard-of-care treatment according to local guidelines or to the decision of the attending physicians., Normal saline 0.9% or 5% dextrose water, Standard-of-care treatment according to local guidelines or to the decision of the attending physicians
Hellenic Institute for the Study of Sepsis
Clostridioides Difficile Infection, Stool Microbiome, Organ Dysfunction Syndrome, Clostridioides Difficile Infection Recurrence, Mortality
06/23
06/23
NCT06061081: A Study to Investigate the Antiviral Effect, Safety, Tolerability and Pharmacokinetics of VH3739937 in in Treatment-Naive Adults Living With HIV-1

Suspended
2
26
Europe, US, RoW
VH3739937, Placebo
ViiV Healthcare
HIV Infections
11/24
11/24
INSPIRE, NCT05785442: Use of Presepsin as a Marker for Immunotherapy Administration in Pneumonia

Completed
2
60
Europe
Anakinra Prefilled Syringe, Kineret, Placebo, NaCl
Hellenic Institute for the Study of Sepsis
Community-acquired Pneumonia, Hospital-acquired Pneumonia
06/24
06/24
BIOARTE, NCT06141395: NGS-Based Assay of Blood Samples of Sepsis Patients for Rapid Bacterial Identification

Completed
N/A
100
Europe
NGS-based assay for bacterial identification
Hellenic Institute for the Study of Sepsis, The BioArte
Pneumonia, Acute Pyelonephritis, Bacteremia, Biliary Tract Infection
03/24
03/24
Boumpas, Dimitrios
BE-EARLY, NCT06411249: A Study Describing the Efficacy and Safety of Belimumab Administered in Adult Participants With Early Systemic Lupus Erythematosus (SLE)

Recruiting
4
350
Europe, Japan, US, RoW
Belimumab (GSK1550188), BEL (BENLYSTA)
GlaxoSmithKline
Systemic Lupus Erythematosus
05/27
05/29
Neptuno, NCT04784559 / 2020-005951-19: Trial to Determine the Efficacy/Safety of Plitidepsin vs Control in Patients With Moderate COVID-19 Infection

Terminated
3
205
Europe, RoW
Plitidepsin, Dexamethasone, Remdesivir, Favipiravir
PharmaMar
COVID-19 Infection
03/23
03/23
BEconneCTD-ILD, NCT06572384: A Study of the Efficacy and Safety of Belimumab in Adults With Interstitial Lung Disease Associated With Connective Tissue Disease

Recruiting
3
440
Europe, Japan, US, RoW
Belimumab, BENLYSTA, GSK1550188, Placebo
GlaxoSmithKline
Lung Diseases, Interstitial
10/28
12/28
NCT06716606: A Study to Investigate the Long-term Safety and Efficacy of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung Disease

Recruiting
3
225
RoW
Belimumab
GlaxoSmithKline, ICON plc
Bronchial Diseases
07/28
01/30
TOPAZ-1, NCT04895241 / 2020-005775-12: A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus

Checkmark Trial initiation of TOPAZ-1 trial in lupus
Jun 2021 - Jun 2021: Trial initiation of TOPAZ-1 trial in lupus
Recruiting
3
540
Europe, US, RoW
Litifilimab, BIIB059, Placebo
Biogen
Lupus Erythematosus, Systemic
09/26
03/27
BLISSc-ILD, NCT05878717: A Study of the Efficacy and Safety of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung Disease

Hourglass Jan 2021 - Jun 2021 : Submission in combination with rituximab for SLE
Recruiting
3
300
Europe, Japan, US, RoW
Belimumab, BENLYSTA™, GSK1550188, LymphoStat-B™, BENLYSTATM, GSK1550188, LymphoStat-B™, Placebo
GlaxoSmithKline
Systemic Sclerosis Associated Interstitial Lung Disease, Scleroderma, Systemic
05/27
07/27
RESOLUTION-1, NCT05516758: A Study of Peresolimab (LY3462817) in Participants With Moderately-to-Severely Active Rheumatoid Arthritis

Completed
2
491
Europe, Canada, Japan, US, RoW
Peresolimab, Placebo
Eli Lilly and Company
Rheumatoid Arthritis, Arthritis, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases, Connective Tissue Diseases, Autoimmune Diseases, Immune System Diseases
11/23
01/25
empacific, NCT06284954: A Study to Evaluate Safety and Efficacy of Empasiprubart in Adults With Dermatomyositis

Recruiting
2
42
Europe, US, RoW
Empasiprubart IV, ARGX-117, Placebo IV
argenx
Dermatomyositis, Myositis
07/25
01/28
SunStone, NCT06559163: A Study of Obexelimab in Patients with Systemic Lupus Erythematosus

Recruiting
2
190
Europe, Canada, Japan, US, RoW
Obexelimab, Placebo
Zenas BioPharma (USA), LLC
Systemic Lupus Erythematosus
06/26
09/26
NCT04570306: Transcriptional and Immune Parameters of Response to Belimumab

Completed
N/A
85
Europe
Belimumab
Biomedical Research Foundation, Academy of Athens, Attikon University General Hospital, Athens, University Hospital of Heraklion, GlaxoSmithKline
Systemic Lupus Erythematosus
12/23
12/23
Kyriazopoulou, Evdoxia
MODIFY, NCT05909683: Assessing the Procalcitonin-guidance and Molecular-guided Diagnosis for Therapy of Severe Infections (the Trial)

Recruiting
3
190
Europe
Change of antimicrobials based on BCID2 and Reveal Rapid AST tests. Stop of antimicrobials based on PCT results., Standard of Care
Hellenic Institute for the Study of Sepsis
Sepsis
07/25
07/25
Antoniadou, Anastasia
MARIO, NCT05178862 / 2022-000648-32: A Phase 3, Randomized, Double-blind Study for Patients With Invasive Candidiasis Treated With IV Echinocandin Followed by Either Oral Ibrexafungerp or Oral Fluconazole

Suspended
3
220
Europe, Canada, US, RoW
SCY-078, Ibrexafungerp, Fluconazole, Diflucan, Echinocandin, Caspofungin, Micafungin, Anidulafungin
Scynexis, Inc., SCYNEXIS, Inc.
Candidiasis, Invasive, Candidemia
06/24
08/24
INSIGHT12, NCT04910269 / 2021-001663-24: Outpatient Treatment With Anti-Coronavirus Immunoglobulin

Recruiting
3
820
Europe, US, RoW
Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG), Placebo
University of Minnesota, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)
COVID, SARS-CoV2 Infection, Covid19
08/26
08/26
Psarrakis, Christos
PRECISION, NCT05926505 / 2023-000102-25: Safety and Efficacy of Anakinra Treatment for Patients With Post Acute Covid Syndrome

Recruiting
2/3
182
Europe
Placebo, Anakinra 149 MG/ML Prefilled Syringe [Kineret]
Hellenic Institute for the Study of Sepsis, Hellenic Institute for the Study of Sepsis
Post-Acute COVID-19 Syndrome, Post-Acute COVID-19, Long COVID
08/25
08/25
BEYOND, NCT05304715 / 2021-005473-10: Bezlotoxumab Yielded Outcomes by Addressing Personalized Needs in Clostridioides Difficile Infection

Completed
2
44
Europe
Bezlotoxumab, Standard-of-care treatment according to local guidelines or to the decision of the attending physicians., Normal saline 0.9% or 5% dextrose water, Standard-of-care treatment according to local guidelines or to the decision of the attending physicians
Hellenic Institute for the Study of Sepsis
Clostridioides Difficile Infection, Stool Microbiome, Organ Dysfunction Syndrome, Clostridioides Difficile Infection Recurrence, Mortality
06/23
06/23
Lambropoulou, Maria
BEYOND, NCT05304715 / 2021-005473-10: Bezlotoxumab Yielded Outcomes by Addressing Personalized Needs in Clostridioides Difficile Infection

Completed
2
44
Europe
Bezlotoxumab, Standard-of-care treatment according to local guidelines or to the decision of the attending physicians., Normal saline 0.9% or 5% dextrose water, Standard-of-care treatment according to local guidelines or to the decision of the attending physicians
Hellenic Institute for the Study of Sepsis
Clostridioides Difficile Infection, Stool Microbiome, Organ Dysfunction Syndrome, Clostridioides Difficile Infection Recurrence, Mortality
06/23
06/23
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Giamarellos-Bourboulis, Evangelos J
ACCESS, NCT04724044: Anti-inflammatory Action of Oral Clarithromycin in Community-acquired Pneumonia

Completed
3
278
Europe
Tablets, 2g of intravenous ceftriaxone or one β-lactam/β-lactamase combination(dose adjusted according to renal clearance) or 400mg of intravenous moxifloxacin, Clarithromycin 500mg
Hellenic Institute for the Study of Sepsis
Community-acquired Pneumonia, Sepsis, Inflammatory Response, Mortality, Biomarkers, SIRS
04/23
04/23
REACT, NCT06294600: Clarithromycin Treatment to Prevent Sepsis Progression in CAP

Recruiting
3
330
Europe
Clarithromycin 500mg, A β-lactam/β-lactamase inhibitor or a 3rd generation cephalosporin or a fluoroquinolone, Tablets
Hellenic Institute for the Study of Sepsis
Community-acquired Pneumonia
11/25
01/26
MODIFY, NCT05909683: Assessing the Procalcitonin-guidance and Molecular-guided Diagnosis for Therapy of Severe Infections (the Trial)

Recruiting
3
190
Europe
Change of antimicrobials based on BCID2 and Reveal Rapid AST tests. Stop of antimicrobials based on PCT results., Standard of Care
Hellenic Institute for the Study of Sepsis
Sepsis
07/25
07/25
PRECISION, NCT05926505 / 2023-000102-25: Safety and Efficacy of Anakinra Treatment for Patients With Post Acute Covid Syndrome

Recruiting
2/3
182
Europe
Placebo, Anakinra 149 MG/ML Prefilled Syringe [Kineret]
Hellenic Institute for the Study of Sepsis, Hellenic Institute for the Study of Sepsis
Post-Acute COVID-19 Syndrome, Post-Acute COVID-19, Long COVID
08/25
08/25
NCT05279352 / 2021-002390-25: Safety and Pharmacokinetics of FBR-002 for the Treatment of Patients Hospitalized With COVID-19 in Need of Supplemental Oxygen and at Risk of Severe Outcome

Recruiting
2a
30
Europe
FBR-002, Placebo
Fab'entech, European Commission (Hera incubator - EPIC Crown-2 project)
COVID-19
06/22
07/22
BEYOND, NCT05304715 / 2021-005473-10: Bezlotoxumab Yielded Outcomes by Addressing Personalized Needs in Clostridioides Difficile Infection

Completed
2
44
Europe
Bezlotoxumab, Standard-of-care treatment according to local guidelines or to the decision of the attending physicians., Normal saline 0.9% or 5% dextrose water, Standard-of-care treatment according to local guidelines or to the decision of the attending physicians
Hellenic Institute for the Study of Sepsis
Clostridioides Difficile Infection, Stool Microbiome, Organ Dysfunction Syndrome, Clostridioides Difficile Infection Recurrence, Mortality
06/23
06/23
NCT04979052: Safety and Efficacy of Interferon-Gamma 1b in Patients With Candidemia

Recruiting
2
200
Europe, US
Interferon Gamma-1B, Immukin
Radboud University Medical Center, Horizon 2020 - European Commission
Candidemia
06/26
06/26
INSPIRE, NCT05785442: Use of Presepsin as a Marker for Immunotherapy Administration in Pneumonia

Completed
2
60
Europe
Anakinra Prefilled Syringe, Kineret, Placebo, NaCl
Hellenic Institute for the Study of Sepsis
Community-acquired Pneumonia, Hospital-acquired Pneumonia
06/24
06/24
NCT06694701: Emapalumab Treatment for Anticipated Clinical Benefit in Sepsis Driven by the Interferon-Gamma Endotype (The EMBRACE Trial)

Recruiting
2
75
Europe
Emapalumab-Izsg, Emapalumab Group 1, Emapalumab Group 2, Placebo
Hellenic Institute for the Study of Sepsis
Sepsis
11/26
11/26
NCT04063332: Functionality of Endogenous Biological Clock in Sepsis

Recruiting
N/A
60
Europe
University of Athens, Hellenic Sepsis Study Group
Circadian Rhythm Disorders, Sepsis
06/24
06/24
NCT05059808: European Sepsis Care Survey

Completed
N/A
1450
Europe, RoW
University Medicine Greifswald, European Sepsis Alliance, European Society of Anaesthesiology and Intensive Care, European Society for Emergency Medicine (EUSEM) Research Network, European Society of Clinical Microbiology and Infectious Diseases, ESGBIES Study Group, European Society of Intensive Care Medicine, Sepsisdialog, Germany, European Shock Society, Becton, Dickinson and Company
Sepsis
04/22
10/22
BEYOND, NCT04725123: Addressing Personalized Needs in Clostridioides Difficile Infection

Completed
N/A
153
Europe
Microbiome analysis
Hellenic Institute for the Study of Sepsis
Clostridioides Difficile Infection
03/22
03/22
SEPSIS-SHIELD, NCT04094818: TriVerity in the Diagnosis and Prognosis of Emergency Department Patients With Suspected Infections and Suspected Sepsis

Completed
N/A
1441
Europe, US
TriVerity, InSep, HostDx Sepsis
Inflammatix
Respiratory Tract Infections, Urinary Tract Infections, Intra-Abdominal Infections, Skin and Soft Tissue Infection, Suspected Meningitis/Encephalitis or Any Other Infection, Sepsis
08/24
09/24
CRONUS, NCT05897801: Distinguishing Bacterial and Viral Infections by MeMed BV® Test to Limit Gut Colonization by MDRO

Completed
N/A
230
Europe
MeMed BV®
Hellenic Institute for the Study of Sepsis
Viral Infection, Bacterial Infections, Multi-antibiotic Resistance, Respiratory Tract Infections
12/23
01/24
BIOARTE, NCT06141395: NGS-Based Assay of Blood Samples of Sepsis Patients for Rapid Bacterial Identification

Completed
N/A
100
Europe
NGS-based assay for bacterial identification
Hellenic Institute for the Study of Sepsis, The BioArte
Pneumonia, Acute Pyelonephritis, Bacteremia, Biliary Tract Infection
03/24
03/24
HOMI-LUNG CAP, NCT06601998: Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19.

Recruiting
N/A
650
Europe
Blood samples and Oropharyngeal swab, Six-minute walk test, Spirometry, ECG, Heart ultrasound and cardiopulmonary exercise stress testing, Completion of questionnaires of symptoms
Hellenic Institute for the Study of Sepsis
Pneumonia, Community-Acquired, COVID-19 Pneumonia, Cardiovascular Diseases
11/27
11/27
POINT, NCT06608849: The Incidence of Pulmonary, Cardiovascular and Renal System Non-communicable Complications Associated with the Post-acute Phase of the Infection by Covid-19

Recruiting
N/A
345
Europe
Blood samples, Six-minute walk test, Spirometry, HRCT, Heart ultrasound, Completion of questionnaires of symptoms
Hellenic Institute for the Study of Sepsis
Pulmonary Complications, Cardiovascular Complications, Renal Complications, COVID-19
11/27
11/27
PROACT, NCT06092554: Probiotics to Actively Counter Ventilator Associated Pneumonia

Recruiting
N/A
186
Europe
LactoLevure, Placebo
University of Bari, Uni-Pharma
Ventilator Associated Pneumonia
05/25
05/25
Papadopoulos, Antonios
REACT, NCT06294600: Clarithromycin Treatment to Prevent Sepsis Progression in CAP

Recruiting
3
330
Europe
Clarithromycin 500mg, A β-lactam/β-lactamase inhibitor or a 3rd generation cephalosporin or a fluoroquinolone, Tablets
Hellenic Institute for the Study of Sepsis
Community-acquired Pneumonia
11/25
01/26
ImmunoSep, NCT04990232 / 2020-005768-74: Personalized Immunotherapy in Sepsis

Completed
2
280
Europe
Anakinra or rhIFNγ, Imukin, Kineret, Placebo
Hellenic Institute for the Study of Sepsis
Sepsis
02/24
04/24
BEYOND, NCT05304715 / 2021-005473-10: Bezlotoxumab Yielded Outcomes by Addressing Personalized Needs in Clostridioides Difficile Infection

Completed
2
44
Europe
Bezlotoxumab, Standard-of-care treatment according to local guidelines or to the decision of the attending physicians., Normal saline 0.9% or 5% dextrose water, Standard-of-care treatment according to local guidelines or to the decision of the attending physicians
Hellenic Institute for the Study of Sepsis
Clostridioides Difficile Infection, Stool Microbiome, Organ Dysfunction Syndrome, Clostridioides Difficile Infection Recurrence, Mortality
06/23
06/23
NCT06061081: A Study to Investigate the Antiviral Effect, Safety, Tolerability and Pharmacokinetics of VH3739937 in in Treatment-Naive Adults Living With HIV-1

Suspended
2
26
Europe, US, RoW
VH3739937, Placebo
ViiV Healthcare
HIV Infections
11/24
11/24
INSPIRE, NCT05785442: Use of Presepsin as a Marker for Immunotherapy Administration in Pneumonia

Completed
2
60
Europe
Anakinra Prefilled Syringe, Kineret, Placebo, NaCl
Hellenic Institute for the Study of Sepsis
Community-acquired Pneumonia, Hospital-acquired Pneumonia
06/24
06/24
BIOARTE, NCT06141395: NGS-Based Assay of Blood Samples of Sepsis Patients for Rapid Bacterial Identification

Completed
N/A
100
Europe
NGS-based assay for bacterial identification
Hellenic Institute for the Study of Sepsis, The BioArte
Pneumonia, Acute Pyelonephritis, Bacteremia, Biliary Tract Infection
03/24
03/24
Boumpas, Dimitrios
BE-EARLY, NCT06411249: A Study Describing the Efficacy and Safety of Belimumab Administered in Adult Participants With Early Systemic Lupus Erythematosus (SLE)

Recruiting
4
350
Europe, Japan, US, RoW
Belimumab (GSK1550188), BEL (BENLYSTA)
GlaxoSmithKline
Systemic Lupus Erythematosus
05/27
05/29
Neptuno, NCT04784559 / 2020-005951-19: Trial to Determine the Efficacy/Safety of Plitidepsin vs Control in Patients With Moderate COVID-19 Infection

Terminated
3
205
Europe, RoW
Plitidepsin, Dexamethasone, Remdesivir, Favipiravir
PharmaMar
COVID-19 Infection
03/23
03/23
BEconneCTD-ILD, NCT06572384: A Study of the Efficacy and Safety of Belimumab in Adults With Interstitial Lung Disease Associated With Connective Tissue Disease

Recruiting
3
440
Europe, Japan, US, RoW
Belimumab, BENLYSTA, GSK1550188, Placebo
GlaxoSmithKline
Lung Diseases, Interstitial
10/28
12/28
NCT06716606: A Study to Investigate the Long-term Safety and Efficacy of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung Disease

Recruiting
3
225
RoW
Belimumab
GlaxoSmithKline, ICON plc
Bronchial Diseases
07/28
01/30
TOPAZ-1, NCT04895241 / 2020-005775-12: A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus

Checkmark Trial initiation of TOPAZ-1 trial in lupus
Jun 2021 - Jun 2021: Trial initiation of TOPAZ-1 trial in lupus
Recruiting
3
540
Europe, US, RoW
Litifilimab, BIIB059, Placebo
Biogen
Lupus Erythematosus, Systemic
09/26
03/27
BLISSc-ILD, NCT05878717: A Study of the Efficacy and Safety of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung Disease

Hourglass Jan 2021 - Jun 2021 : Submission in combination with rituximab for SLE
Recruiting
3
300
Europe, Japan, US, RoW
Belimumab, BENLYSTA™, GSK1550188, LymphoStat-B™, BENLYSTATM, GSK1550188, LymphoStat-B™, Placebo
GlaxoSmithKline
Systemic Sclerosis Associated Interstitial Lung Disease, Scleroderma, Systemic
05/27
07/27
RESOLUTION-1, NCT05516758: A Study of Peresolimab (LY3462817) in Participants With Moderately-to-Severely Active Rheumatoid Arthritis

Completed
2
491
Europe, Canada, Japan, US, RoW
Peresolimab, Placebo
Eli Lilly and Company
Rheumatoid Arthritis, Arthritis, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases, Connective Tissue Diseases, Autoimmune Diseases, Immune System Diseases
11/23
01/25
empacific, NCT06284954: A Study to Evaluate Safety and Efficacy of Empasiprubart in Adults With Dermatomyositis

Recruiting
2
42
Europe, US, RoW
Empasiprubart IV, ARGX-117, Placebo IV
argenx
Dermatomyositis, Myositis
07/25
01/28
SunStone, NCT06559163: A Study of Obexelimab in Patients with Systemic Lupus Erythematosus

Recruiting
2
190
Europe, Canada, Japan, US, RoW
Obexelimab, Placebo
Zenas BioPharma (USA), LLC
Systemic Lupus Erythematosus
06/26
09/26
NCT04570306: Transcriptional and Immune Parameters of Response to Belimumab

Completed
N/A
85
Europe
Belimumab
Biomedical Research Foundation, Academy of Athens, Attikon University General Hospital, Athens, University Hospital of Heraklion, GlaxoSmithKline
Systemic Lupus Erythematosus
12/23
12/23
Kyriazopoulou, Evdoxia
MODIFY, NCT05909683: Assessing the Procalcitonin-guidance and Molecular-guided Diagnosis for Therapy of Severe Infections (the Trial)

Recruiting
3
190
Europe
Change of antimicrobials based on BCID2 and Reveal Rapid AST tests. Stop of antimicrobials based on PCT results., Standard of Care
Hellenic Institute for the Study of Sepsis
Sepsis
07/25
07/25
Antoniadou, Anastasia
MARIO, NCT05178862 / 2022-000648-32: A Phase 3, Randomized, Double-blind Study for Patients With Invasive Candidiasis Treated With IV Echinocandin Followed by Either Oral Ibrexafungerp or Oral Fluconazole

Suspended
3
220
Europe, Canada, US, RoW
SCY-078, Ibrexafungerp, Fluconazole, Diflucan, Echinocandin, Caspofungin, Micafungin, Anidulafungin
Scynexis, Inc., SCYNEXIS, Inc.
Candidiasis, Invasive, Candidemia
06/24
08/24
INSIGHT12, NCT04910269 / 2021-001663-24: Outpatient Treatment With Anti-Coronavirus Immunoglobulin

Recruiting
3
820
Europe, US, RoW
Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG), Placebo
University of Minnesota, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)
COVID, SARS-CoV2 Infection, Covid19
08/26
08/26
Psarrakis, Christos
PRECISION, NCT05926505 / 2023-000102-25: Safety and Efficacy of Anakinra Treatment for Patients With Post Acute Covid Syndrome

Recruiting
2/3
182
Europe
Placebo, Anakinra 149 MG/ML Prefilled Syringe [Kineret]
Hellenic Institute for the Study of Sepsis, Hellenic Institute for the Study of Sepsis
Post-Acute COVID-19 Syndrome, Post-Acute COVID-19, Long COVID
08/25
08/25
BEYOND, NCT05304715 / 2021-005473-10: Bezlotoxumab Yielded Outcomes by Addressing Personalized Needs in Clostridioides Difficile Infection

Completed
2
44
Europe
Bezlotoxumab, Standard-of-care treatment according to local guidelines or to the decision of the attending physicians., Normal saline 0.9% or 5% dextrose water, Standard-of-care treatment according to local guidelines or to the decision of the attending physicians
Hellenic Institute for the Study of Sepsis
Clostridioides Difficile Infection, Stool Microbiome, Organ Dysfunction Syndrome, Clostridioides Difficile Infection Recurrence, Mortality
06/23
06/23
Lambropoulou, Maria
BEYOND, NCT05304715 / 2021-005473-10: Bezlotoxumab Yielded Outcomes by Addressing Personalized Needs in Clostridioides Difficile Infection

Completed
2
44
Europe
Bezlotoxumab, Standard-of-care treatment according to local guidelines or to the decision of the attending physicians., Normal saline 0.9% or 5% dextrose water, Standard-of-care treatment according to local guidelines or to the decision of the attending physicians
Hellenic Institute for the Study of Sepsis
Clostridioides Difficile Infection, Stool Microbiome, Organ Dysfunction Syndrome, Clostridioides Difficile Infection Recurrence, Mortality
06/23
06/23

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