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Personalized Immunotherapy in Sepsis (ImmunoSep)

Primary Purpose

Sepsis

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Anakinra or rhIFNγ
Placebo
Sponsored by
Hellenic Institute for the Study of Sepsis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sepsis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age equal to or above 18 years.
  • Both genders.
  • In case of women, unwillingness to become pregnant during the study period.
  • Written informed consent provided by the patient or by one first-degree relative/spouse in case of patients unable to consent.
  • Community-acquired pneumonia (CAP) or hospital-acquired pneumonia (HAP) or ventilator-associated pneumonia (VAP) or primary bacteremia (BSI).
  • Sepsis defined by the Sepsis-3 definitions. More precisely, sepsis is defined as the presence of total SOFA (sequential organ failure assessment score) equal to 2 or more for patients who are admitted with infection at the emergency department OR as any increase of admission SOFA by 2 or more points for patients already hospitalized.
  • Patients with signs of fulminant hyper-inflammation or sepsis-associated immunoparalysis as defined by ferritin and Quantibrite. Since the state of hyper-inflammation is considered more life-threatening than the state of immunoparalysis, patients with lab findings of both immune states are allocated to treatment targeting hyper-inflammation. It is explicitly stated that patients diagnosed with novel Coronavirus-2 infection (COVID-19) may participate only in the fulminant hyper-inflammation arm
  • Time from classification into sepsis by the Sepsis-3 definitions and start of blind intervention less than 72 hours.

Exclusion Criteria:

  • Age below 18 years.
  • Denial for written informed consent.
  • Acute pyelonephritis or intraabdominal infection, meningitis or skin infection.
  • Any stage IV malignancy.
  • Neutropenia defined as an absolute neutrophil count lower than 1,500/mm3.
  • Any 'do not resuscitate' decision in the hospital.
  • In the case of BSI, patients with blood cultures growing coagulase-negative staphylococci or skin commensals or catheter-related infections cannot be enrolled.
  • Active tuberculosis (TB) as defined by the co-administration of drugs for the treatment of TB.
  • Infection by the human immunodeficiency virus (HIV).
  • Any primary immunodeficiency.
  • Oral or intravenous intake of corticosteroids at a daily dose equal or greater than 0.4 mg/kg prednisone or greater the last 15 days.
  • Any anti-cytokine biological treatment the last one month.
  • Medical history of systemic lupus erythematosus.
  • Medical history of multiple sclerosis or any other demyelinating disorder.
  • Pregnancy or lactation. Women of child-bearing potential will be screened by a urine pregnancy test before inclusion in the study.

Sites / Locations

  • Intensive Care Unit, Jena University HospitalRecruiting
  • 2nd Department of Critical Care Medicine, ATTIKON University HospitalRecruiting
  • Intensive Care Unit, Ioannina University HospitalRecruiting
  • Intensive Care Unit, Center for Accident Rehabilitation (KAT) of AthensRecruiting
  • Intensive Care Unit, Alexandroupolis University HospitalRecruiting
  • 1ST Department of Internal Medicine, Evangelismos General HospitalRecruiting
  • 1st Department of Pulmonary Medicine and Intensive Care UnitRecruiting
  • 3rd University Department of Internal Medicine, General Hospital of Chest Diseases of Athens SOTIRIARecruiting
  • Intensive Care Unit of Center for Respiratory Failure, General Hospital of Chest Diseases of Athens SOTIRIARecruiting
  • New Intensive Care Unit, SOTIRIA Athens General Hospital of Chest DiseasesRecruiting
  • 4th Department of Internal Medicine, "Attikon" University Hospital, National and Kapodistrian University of Athens, Medical SchoolRecruiting
  • Intensive Care Unit, General Hospital ASKLEPIEIO VoulasRecruiting
  • 2nd Department of Internal Medicine, Attikon University HospitalRecruiting
  • 5th Department of Internal Medicine, Evangelismos General Hospital
  • General Oncological Hospital of Kifisia Oi Agioi Anargyroi - Clinic of Intensive Care and Pulmonary Diseases Department of Nursing, University of AthensRecruiting
  • Greece Intensive Care Unit General Hospital of Athens KorgialeneioRecruiting
  • Intensive Care Unit, "Latsio", Thriasio Elefsis General HospitalRecruiting
  • Greece Intensive Care Unit University General Hospital of HeraklionRecruiting
  • General Hospital of Karditsa Intensive Care UnitRecruiting
  • Intensive Care Unit, "Koutlimbaneio & Triantafylleio" Larissa General HospitalRecruiting
  • Department of Internal Medicine, Larissa University HospitalRecruiting
  • Intensive Care Unit, TZANEIO Piraeus General HospitalRecruiting
  • Intensive Care Unit, Agios Dimitrios General HospitalRecruiting
  • Intensive Care Unit, G. Gennimatas General HospitalRecruiting
  • Intensive Care Unit, Theageneio Oncological Hospital of ThessalonikiRecruiting
  • Intensive Care Unit, Ippokrateion General HospitalRecruiting
  • Department of Anesthesiology and Intensive Care Medicine, University General Hospital of Thessaloniki AHEPARecruiting
  • Intensive Care Unit, 424 General Military Training HospitalRecruiting
  • Department of Internal Medicine and Infectious Diseases, Amsterdam Medical CenterRecruiting
  • Intensive Care Unit, University Medical Center RadboudRecruiting
  • Infectious Diseases Department, "Iuliu Hatieganu'' University of Medicine and Pharmacy Cluj-NapocaRecruiting
  • Intensive Care Unit, Centre Hospitalier Universitaire Vaudois (CHUV)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Standard of care

Immunotherapy

Arm Description

Patients will receive the standard type of treatment decided by the attending physicians. They will also receive 20ml (10ml for patients with creatinine clearance lower than 30ml/min) intravenous (IV) 0.9% saline (N/S) three times daily (every eight hours) for 15 days and 0.5 ml subcutaneous (sc) 1ml 0.9% N/S every other day for a total of 15 days.

Patients will receive the standard type of treatment decided by the attending physicians. They will also receive IV anakinra 200 mg three times daily (every eight hours) or sc rhIFNγ 100 μg once every other day. More precisely, patients randomized for hyper-inflammation will receive anakinra three times daily (every eight hours) for 15 days and sc 0.5 ml N/S 0.9% every other day for 15 days. Patients having immunoparalysis will receive IV 20 ml N/S 0.9% (10ml for patients with creatinine clearance lower than 30ml/min) three times daily (every eight hours) for 15 days and sc rhIFNγ every other day for 15 days. Especially for patients with creatinine clearance lower than 30 ml/min anakinra will be given half dose (i.e. 100 mg three times daily). Creatinine clearance is calculated by the Cockcroft Gault equation [(140-age in years)/ (72 x serum creatinine in mg/dl) for men; this is multiplied by 0.85 for women.

Outcomes

Primary Outcome Measures

Mean total Sequential Organ Failure Assessment score
Difference in the mean total Sequential Organ Failure Assessment score between the two arms

Secondary Outcome Measures

28-day mortality
Difference in mortality between the two arms
90-day mortality
Difference in mortality between the two arms
Mean total Sequential Organ Failure Assessment score
Difference in the mean total Sequential Organ Failure Assessment score between the two arms
Reversal of hyper-inflammation (decrease of ferritin) or immunoparalysis (increase of Quantibrite)
Difference in percentage of patients between the two arms with any at least 15% decrease of the baseline serum ferritin (if in hyper-inflammation) and with any Quantibrite to above 8,000 AB/C with serum ferritin below 4,420 ng/ml (if in sepsis-associated immunoparalysis)

Full Information

First Posted
July 29, 2021
Last Updated
October 6, 2023
Sponsor
Hellenic Institute for the Study of Sepsis
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1. Study Identification

Unique Protocol Identification Number
NCT04990232
Brief Title
Personalized Immunotherapy in Sepsis
Acronym
ImmunoSep
Official Title
Personalized Immunotherapy in Sepsis: a Multicentre and Multinational, Double-blind, Double-dummy Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 29, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
July 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hellenic Institute for the Study of Sepsis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Αim of ImmunoSep is to assess whether personalized adjunctive immunotherapy directed against a state of either fulminant hyper-inflammation or immunoparalysis is able to change sepsis outcomes. Patients will be selected by a panel of biomarkers and laboratory findings and will be allocated to placebo or immunotherapy treatment according to their needs.
Detailed Description
Sepsis is a life-threatening organ dysfunction that results from the dysregulated host response to an infection. Accumulating knowledge suggests that there is a spectrum of dysregulation in this response. On the one end of this spectrum there are patients whose immune response is characterized by fulminant hyper-inflammation. On the other end of this spectrum there are patients whose immune response is characterized by immunoparalysis. The majority of patients are situated between these two extremes. The primary hypothesis of the ImmunoSep trial is to recognize both ends of this spectrum and to administer adjunctive therapy aiming to modulate the sepsis-associated hyper-inflammation or immunoparalysis. It is anticipated that with this strategy patients' organ dysfunctions be improved. During the last years the Hellenic Sepsis Study Group (HSSG) managed to develop ferritin as the diagnostic tool for the recognition of patients with fulminant sepsis-associated hyper-inflammation. This was done by analysis of 5,121 patients split into a test and a validation cohort and by also studying a confirmation cohort coming from Sweden. Patients were classified according to the criteria for the macrophage activation syndrome developed by the American College of Rheumatology; approximately 4% of patients with sepsis have fulminant hyper-inflammation or macrophage activation-like syndrome (MALS) that is an independent clinical condition associated with short-term 10-day mortality. Serum ferritin greater than 4,420 ng/ml had sensitivity 97.1% and negative predictive value 98% for the diagnosis. More than 25 years ago one randomized clinical trial (RCT) was conducted where patients with severe sepsis were randomly assigned to blind treatment with placebo or with the recombinant human interleukin-1 receptor antagonist anakinra. The trial failed to disclose any benefit of anakinra on 28-day mortality. However, a recent post-hoc analysis revealed that patients who had signs of macrophage activation syndrome had significant 30% survival benefit by anakinra treatment. The immunoparalysis of sepsis is associated with at least 50% risk of death in the subsequent 28 days. There is evidence from preclinical studies and from the endotoxin challenge model in human volunteers that this can be reversed using recombinant human interferon gamma (rhIFNγ). rhIFNγ was administered in nine patients with septic shock in a small open-label clinical trial without placebo comparator; reversal of immunoparalysis was achieved. It is important to recognize patients with sepsis complicated either with MALS or with immunoparalysis and administer anakinra or rhIFNγ respectively as a potentially beneficial intervention. To this end, a smaller-scale trial was conducted in Greece that was aiming to the personalized management of septic shock. The acronym of this trial was PROVIDE. PROVIDE was conducted between December 2017 and December 2019 in 14 study sites in Greece under the auspices of the European Shock Society. In the PROVIDE trial patients with septic shock due to lower respiratory tract infection, acute cholangitis, or primary bacteremia, were screened on two consecutive days for laboratory signs of fulminant hyper-inflammation or immunoparalysis. Results showed that one single measurement of serum ferritin and the number of human leukocyte antigen-DR (HLA-DR) on monocytes can efficiently classify patients. More precisely, ferritin 4,420 ng/ml diagnoses MALS; and a combination of ferritin >4,420 ng/ml and HLA-DR less than 5000 molecules/monocyte diagnose imunoparalysis. Patients were randomized into double-dummy blind treatment with placebo if randomly assigned to the standard-of-care arm and with anakinra/recombinant human interferon-gamma (rhIFNγ) if randomly assigned to the immunotherapy arm. Thirty-six patients were enrolled and preliminary results derived from the PROVIDE trial further corroborate the use of anakira/rhIFNγ as an innovative, personalized adjunct therapy for sepsis but one larger-scale study with larger number of patients is needed in order to validate findings. ImmunoSep is a randomized placebo-controlled phase 2 clinical trial with a double-dummy design where the effect of personalized immunotherapy in patients with sepsis and either fulminant hyper-inflammation or immunoparalysis is studied. Hyper-inflammation is considered as a more direct life-threatening manifestation of sepsis than immunoparalysis; for that reason patients with lab findings of both immune states are allocated to the hyper-inflammation treatment arm.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
multicentre and multinational, double-blind, double-dummy randomized clinical trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard of care
Arm Type
Placebo Comparator
Arm Description
Patients will receive the standard type of treatment decided by the attending physicians. They will also receive 20ml (10ml for patients with creatinine clearance lower than 30ml/min) intravenous (IV) 0.9% saline (N/S) three times daily (every eight hours) for 15 days and 0.5 ml subcutaneous (sc) 1ml 0.9% N/S every other day for a total of 15 days.
Arm Title
Immunotherapy
Arm Type
Experimental
Arm Description
Patients will receive the standard type of treatment decided by the attending physicians. They will also receive IV anakinra 200 mg three times daily (every eight hours) or sc rhIFNγ 100 μg once every other day. More precisely, patients randomized for hyper-inflammation will receive anakinra three times daily (every eight hours) for 15 days and sc 0.5 ml N/S 0.9% every other day for 15 days. Patients having immunoparalysis will receive IV 20 ml N/S 0.9% (10ml for patients with creatinine clearance lower than 30ml/min) three times daily (every eight hours) for 15 days and sc rhIFNγ every other day for 15 days. Especially for patients with creatinine clearance lower than 30 ml/min anakinra will be given half dose (i.e. 100 mg three times daily). Creatinine clearance is calculated by the Cockcroft Gault equation [(140-age in years)/ (72 x serum creatinine in mg/dl) for men; this is multiplied by 0.85 for women.
Intervention Type
Drug
Intervention Name(s)
Anakinra or rhIFNγ
Other Intervention Name(s)
Imukin, Kineret
Intervention Description
In hyper-inflammation anakinra three times daily (every eight hours) for 15 days and sc 0.5 ml N/S 0.9% every other day for 15 days. In immunoparalysis IV 20 ml N/S 0.9% (10ml for patients with creatinine clearance lower than 30ml/min) three times daily (every eight hours) for 15 days and sc rhIFNγ every other day for 15 days.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
20ml (10ml for patients with creatinine clearance lower than 30ml/min) intravenous (IV) 0.9% saline (N/S) three times daily (every eight hours) for 15 days and 0.5 ml subcutaneous (sc) 1ml 0.9% N/S every other day for a total of 15 days
Primary Outcome Measure Information:
Title
Mean total Sequential Organ Failure Assessment score
Description
Difference in the mean total Sequential Organ Failure Assessment score between the two arms
Time Frame
9 days
Secondary Outcome Measure Information:
Title
28-day mortality
Description
Difference in mortality between the two arms
Time Frame
28 days
Title
90-day mortality
Description
Difference in mortality between the two arms
Time Frame
90 days
Title
Mean total Sequential Organ Failure Assessment score
Description
Difference in the mean total Sequential Organ Failure Assessment score between the two arms
Time Frame
15 days
Title
Reversal of hyper-inflammation (decrease of ferritin) or immunoparalysis (increase of Quantibrite)
Description
Difference in percentage of patients between the two arms with any at least 15% decrease of the baseline serum ferritin (if in hyper-inflammation) and with any Quantibrite to above 8,000 AB/C with serum ferritin below 4,420 ng/ml (if in sepsis-associated immunoparalysis)
Time Frame
15 days
Other Pre-specified Outcome Measures:
Title
Resolution of infection-reversal of all signs and symptoms of the initial infection
Description
Difference in percentage of patients with resolution of the initial infection between the two arms
Time Frame
15 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age equal to or above 18 years. Both genders. In case of women, unwillingness to become pregnant during the study period. Written informed consent provided by the patient or by one first-degree relative/spouse in case of patients unable to consent. Community-acquired pneumonia (CAP) or hospital-acquired pneumonia (HAP) or ventilator-associated pneumonia (VAP) or primary bacteremia (BSI). Sepsis defined by the Sepsis-3 definitions. More precisely, sepsis is defined as the presence of total SOFA (sequential organ failure assessment score) equal to 2 or more for patients who are admitted with infection at the emergency department OR as any increase of admission SOFA by 2 or more points for patients already hospitalized. Patients with signs of fulminant hyper-inflammation or sepsis-associated immunoparalysis as defined by ferritin and Quantibrite. Since the state of hyper-inflammation is considered more life-threatening than the state of immunoparalysis, patients with lab findings of both immune states are allocated to treatment targeting hyper-inflammation. It is explicitly stated that patients diagnosed with novel Coronavirus-2 infection (COVID-19) may participate only in the fulminant hyper-inflammation arm Time from classification into sepsis by the Sepsis-3 definitions and start of blind intervention less than 72 hours. Exclusion Criteria: Age below 18 years. Denial for written informed consent. Acute pyelonephritis or intraabdominal infection, meningitis or skin infection. Any stage IV malignancy. Neutropenia defined as an absolute neutrophil count lower than 1,500/mm3. Any 'do not resuscitate' decision in the hospital. In the case of BSI, patients with blood cultures growing coagulase-negative staphylococci or skin commensals or catheter-related infections cannot be enrolled. Active tuberculosis (TB) as defined by the co-administration of drugs for the treatment of TB. Infection by the human immunodeficiency virus (HIV). Any primary immunodeficiency. Oral or intravenous intake of corticosteroids at a daily dose equal or greater than 0.4 mg/kg prednisone or greater the last 15 days. Any anti-cytokine biological treatment the last one month. Medical history of systemic lupus erythematosus. Medical history of multiple sclerosis or any other demyelinating disorder. Pregnancy or lactation. Women of child-bearing potential will be screened by a urine pregnancy test before inclusion in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Evangelos Giamarellos-Bourboulis, MD, PhD
Phone
00302105831994
Email
egiamarel@med.uoa.gr
First Name & Middle Initial & Last Name or Official Title & Degree
Evdoxia Kyriazopoulou, MD, MSc, PhD
Phone
00302105832563
Email
ekyri@med.uoa.gr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evagelos Giamarellos-Bourboulis, MD, PhD
Organizational Affiliation
Hellenic Institute for the Study of Sepsis
Official's Role
Study Chair
Facility Information:
Facility Name
Intensive Care Unit, Jena University Hospital
City
Jena
ZIP/Postal Code
07747
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Bauer, Prof.Dr.med.
Phone
+49 3641 9323101
Email
michael.bauer@med.uni-jena.de
Facility Name
2nd Department of Critical Care Medicine, ATTIKON University Hospital
City
Athens
State/Province
Haidari
ZIP/Postal Code
12462
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iraklis Tsagkaris, MD, PhD
Phone
+30 6944734600
Email
itsagkaris@med.uoa.gr
Facility Name
Intensive Care Unit, Ioannina University Hospital
City
Ioánnina
State/Province
Ioannina
ZIP/Postal Code
45500
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vassilios Koulouras, MD, PhD
Phone
+306972840476
Email
vpkoulouras@yahoo.gr
Facility Name
Intensive Care Unit, Center for Accident Rehabilitation (KAT) of Athens
City
Athens
State/Province
Kifissia
ZIP/Postal Code
14561
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ioannis Alamanos, MD
Phone
+306932300372
Email
icualamanos@yahoo.gr
Facility Name
Intensive Care Unit, Alexandroupolis University Hospital
City
Alexandroupolis
ZIP/Postal Code
68100
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vasileios Papaioannou, MD
Phone
+306942551414
Email
vapapa@med.duth.gr, papabil69@gmail.com
Facility Name
1ST Department of Internal Medicine, Evangelismos General Hospital
City
Athens
ZIP/Postal Code
10676
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Theano Kontopoulou
Phone
+306944690525
Email
tkontopoulou@yahoo.gr
Facility Name
1st Department of Pulmonary Medicine and Intensive Care Unit
City
Athens
ZIP/Postal Code
11527
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nikoletta Rovina, MD, PhD
Phone
+30 6945830212
Email
nikrovina@med.uoa.gr
Facility Name
3rd University Department of Internal Medicine, General Hospital of Chest Diseases of Athens SOTIRIA
City
Athens
ZIP/Postal Code
11527
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Garyfallia Poulakou, MD, PhD
Phone
+30 6945597583
Email
gpoulakou@gmail.com
Facility Name
Intensive Care Unit of Center for Respiratory Failure, General Hospital of Chest Diseases of Athens SOTIRIA
City
Athens
ZIP/Postal Code
11527
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ioannis Nikolopoulos
Phone
+306938830089
Email
ioa.nikolopoulos@gmail.com
Facility Name
New Intensive Care Unit, SOTIRIA Athens General Hospital of Chest Diseases
City
Athens
ZIP/Postal Code
11527
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Daganou, MD
Phone
+30 6936938341
Email
mdaganou@hotmail.com
Facility Name
4th Department of Internal Medicine, "Attikon" University Hospital, National and Kapodistrian University of Athens, Medical School
City
Athens
ZIP/Postal Code
12462
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonios Papadopoulos, MD, PhD
Phone
00302105831646
Email
antpapa1@otenet.gr
Facility Name
Intensive Care Unit, General Hospital ASKLEPIEIO Voulas
City
Athens
ZIP/Postal Code
16673
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aikaterini Ioakeimidou, MD
Phone
+306974579319
Email
katioakim@gmail.com
Facility Name
2nd Department of Internal Medicine, Attikon University Hospital
City
Athens
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erifili Hatziagelaki, MD, PhD
Email
erihat@otenet.gr
Facility Name
5th Department of Internal Medicine, Evangelismos General Hospital
City
Athens
Country
Greece
Individual Site Status
Completed
Facility Name
General Oncological Hospital of Kifisia Oi Agioi Anargyroi - Clinic of Intensive Care and Pulmonary Diseases Department of Nursing, University of Athens
City
Athens
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pavlos Miranthefs
Phone
+306977774853
Email
pmiriant@nurs.uoa.gr
Facility Name
Greece Intensive Care Unit General Hospital of Athens Korgialeneio
City
Athens
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Patrani
Phone
+30 6946665991
Email
mpatrani@gmail.com
Facility Name
Intensive Care Unit, "Latsio", Thriasio Elefsis General Hospital
City
Elefsína
ZIP/Postal Code
19600
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nikolaos Markou, MD, PhD
Phone
+306973404627
Email
nikolaos_markou@hotmail.com
Facility Name
Greece Intensive Care Unit University General Hospital of Heraklion
City
Heraklion
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kondili Evmorfia
Phone
+306980168974
Email
kondylie@uoc.gr
Facility Name
General Hospital of Karditsa Intensive Care Unit
City
Kardítsa
ZIP/Postal Code
43100
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Theodotou
Phone
+306977678081
Email
annatheodotou@gmail.com
Facility Name
Intensive Care Unit, "Koutlimbaneio & Triantafylleio" Larissa General Hospital
City
Larissa
ZIP/Postal Code
41221
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Apostolos Komnos, MD, PhD
Phone
+306944670163
Email
komnosapo@gmail.com
Facility Name
Department of Internal Medicine, Larissa University Hospital
City
Larissa
ZIP/Postal Code
41334
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
George Dalekos, MD, PhD
Phone
+302410685701
Email
dalekos@med.uth.gr
Facility Name
Intensive Care Unit, TZANEIO Piraeus General Hospital
City
Piraeus
ZIP/Postal Code
18536
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Athanasios Prekates, MD, PhD
Phone
+30 6945580584
Email
prekatesa@yahoo.com
Facility Name
Intensive Care Unit, Agios Dimitrios General Hospital
City
Thessaloniki
ZIP/Postal Code
54 634
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Glykeria Vlachogianni, MD
Phone
0030 2313 322173
Email
glykav@otenet.gr
Facility Name
Intensive Care Unit, G. Gennimatas General Hospital
City
Thessaloniki
ZIP/Postal Code
546 35
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eleni Antoniadou, MD
Phone
0030 2310 963321
Email
eleni.antoniadou@gmail.com
Facility Name
Intensive Care Unit, Theageneio Oncological Hospital of Thessaloniki
City
Thessaloniki
ZIP/Postal Code
546 39
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Souzana Anisoglou, MD
Phone
+30 213 898200
Email
souzanis@freemail.gr
Facility Name
Intensive Care Unit, Ippokrateion General Hospital
City
Thessaloniki
ZIP/Postal Code
546 42
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eleni Mouloudi, MD
Phone
0030 2310 892000
Email
elmoulou@yahoo.gr
Facility Name
Department of Anesthesiology and Intensive Care Medicine, University General Hospital of Thessaloniki AHEPA
City
Thessaloniki
ZIP/Postal Code
54636
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eleni Geka, MD
Phone
+306976445521
Email
gekhel@gmail.com
Facility Name
Intensive Care Unit, 424 General Military Training Hospital
City
Thessaloniki
ZIP/Postal Code
56429
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chrysoula Pazvanti, MD
Phone
+30 6976117537
Email
goldiepaz@yahoo.gr
Facility Name
Department of Internal Medicine and Infectious Diseases, Amsterdam Medical Center
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander P Vlaar, MD
Email
a.p.vlaar@amsterdamumc.nl
Facility Name
Intensive Care Unit, University Medical Center Radboud
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Pickkers, Prof. dr.
Email
peter.pickkers@radboudumc.nl
Facility Name
Infectious Diseases Department, "Iuliu Hatieganu'' University of Medicine and Pharmacy Cluj-Napoca
City
Cluj-Napoca
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mihaela Lupșe, Prof. Dr.
Email
mihaela.lupse@yahoo.com
Facility Name
Intensive Care Unit, Centre Hospitalier Universitaire Vaudois (CHUV)
City
Lausanne
ZIP/Postal Code
CH-1011
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thierry F Calandra, MD, PhD
Email
Thierry.Calandra@chuv.ch

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All data will be available within published manuscript. Deidentified patient data can be requested to Sponsor and shared after approval for purposed approved by Sponsor.
IPD Sharing Time Frame
Upon publication of manuscript related to this study
IPD Sharing Access Criteria
After contact with sponsor (egiamarel@med.uoa.gr)

Learn more about this trial

Personalized Immunotherapy in Sepsis

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