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The activities of the Hellenic Institute for the Study of Sepsis

Our Fight

A continuous effort

Support of the activities of the Hellenic Sepsis Study Group (HSSG)

The HSSG is a scientific collaboration running research in 65 study sites centers (31 Departments of Internal Medicine; 3 Departments of Pulmonary Medicine; 6 Departments of Surgery; 25 Intensive Care Units) in Greece and Cyprus through the collection of clinical information and biosamples of patients with severe infections. Until today clinical data and samples of DNA/RNA/serum from more than 5,500 patients have been collected and stored in the biobank of the HISS. The support provided by the HISS comprises courier services, central lab, monitoring, collection of data, analysis of data and drafting of manuscripts. The publications coming from this collaboration under the auspices of the HISS are listed below:

1. Poukoulidou T, Spyridaki A, Michailidou I, Kopterides P, Pistiki A, Alexiou Z, Chrisofos M, Dimopoulou I, Drimoussis P, Giamarellos-Bourboulis EJ, Koutelidakis I, Marioli A, Mega A, Orfanos SE, Theodorakopoulou M, Tsironis C, Maggina N, Polychronopoulos V, Tsangaris I. TREM-1 expression on neutrophils and monocytes of septic patients: relation to the underlying infection and the implicated pathogen. BMC Infectious Diseases 2011; 11: 309
2. Giamarellos-Bourboulis EJ, Norrby-Teglund A, Mylona V, Savva A, Tsangaris I, Dimopoulou I, Mouktaroudi M, Raftogannis M, Georgitsi M, Linnér 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, Sundén-Kullberg J, Mega A, Prekates A, Routsi C, Gogos C, Treutiger CJ, Armaganidis A, Dimopoulos G. Risk assessment in sepsis: a new prognostication score by APACHE II score and serum soluble urokinase plasminogen activator receptor. Critical Care 2012; 16: R149
3. Giannikopoulos G, Antonopoulou A Kalpakou G, Makaritsis K, Panou C, Papadomichelakis E, Sinapidis D, Theodotou A, Tzagkaraki A, Giamarellos-Bourboulis EJ. The functional role of natural killer cells early in clinical sepsis. APMIS 2013; 121: 329-336
4. Kritselis I, Tzanetakou V, Adamis G, Anthopoulos G, Antoniadou E, Bristianou M, Kotanidou A, Lignos M, Polyzos K, Retsas T, Sassopoulou P, Papaioannou AI, Sinapidis D, Sereti K, Vittoros V, Ghanas P, Gogos C, Giamarellos-Bourboulis E. The level of endotoxemia in sepsis varies in relation to the underlying infection: impact on final outcome. Immunology Letters 2013; 152: 167-172
5. Pavlaki M, Poulakou G, Drimousis P, Adamis G, Apostolidou E, Gatselis NK, Kritselis I, Mega A, Mylona V, Papatsoris A, Pappas A, Prekates A, Raftogiannis M, Rigaki K, Sereti K, Sinapidis D, Tsangaris I, Tzanetakou V, Veldekis D, Mandragos K, Giamarellou H, Dimopoulos G. Polymicrobial bloodstream infections: epidemiology and impact on mortality. Journal of Global Antimicrobial Resistance 2013; 1: 207-212
6. Giamarellos-Bourboulis EJ, Apostolidou E, Lada M, Perdios I, Gatselis N, Tsangaris I, Georgitsi M, Bristianou M, Kanni T, Sereti K, Kyprianou MA, Kotanidou A, Armaganidis A. Kinetics of circulating immunoglobulin M in sepsis: relationship with final outcome. Critical Care 2013; 17: R247
7. Koupetori M, Retsas T, Antonakos N, Vlachogiannis G, Perdios I, Nathanail C, Makaritsis K, Papadopoulos A, Sinapidis D, Giamarellos-Bourboulis EJ, Pneumatikos I, Gogos C, Armaganidis A, Paramythiotou A. Bloodstream infections and sepsis in Greece: over-time change of epidemiology and impact of de-escalation on final outcome. BMC Infectious Diseases 2014; 14: 272
8. Marioli A, Koupetori M, Raftogiannis M, Patrani M, Antonakos N, Pavlaki M, Adamis G, Dougekou G, Damoraki G, Tsangaris I. Early changes of the kinetics of monocyte trem-1 reflect final outcome in human sepsis. BMC Immunology 2014; 15: 63
9. Lymperopoulou K, Velissaris D, Kotsaki A, Antypa E, Georgiadou S, Tsaganos T, Koulenti D, Paggalou E, Damoraki G, Karagiannidis N, Orfanos SE. Angiopoietin-2 associations with the underlying infection and sepsis severity. Cytokine 2015; 73: 163-168
10. Panayides A, Ioakeimidou A, Karamouzos V, Antonakos N, Koutelidakis I, Giannikopoulos G, Makaritsis K, Voloudakis N, Toutouzas K, Rovina N, Bristianou M, Damoraki G, Routsi C, Giamarellos-Bourboulis EJ. -572 G/C single nucleotide polymorphism of interleukin-6 and sepsis predisposition in chronic renal disease. European Journal of Clinical Microbiology and Infectious Diseases 2015; 34: 2439-2446
11. Georgitsi M, Vittoros V, Panou C, Tsangaris I, Aimoniotou E, Gatselis NK, Chasou E, Kouliatsis G, Leventogiannis K, Velissaris D, Belesiotou E, Dioriotou-Aggaliadou O, Giannitsioti E, Netea MG, Giamarellos-Bourboulis EJ, Giannikopoulos G, Alexiou Z, Voloudakis N, Koutsoukou A. Individualized significance of the -252 A/T single nucleotide polymorphism of interleukιn-8 in severe infections. European Journal of Clinical Microbiology and Infectious Disease 2016; 35: 563-570
12. Tsaganos T, Raftogiannis M, Pratikaki M, Christodoulou S, Kotanidou A, Papadomichelakis E, Armaganidis A, Routsi C, Giamarellos-Bourboulis EJ. Clarithromycin leads to long-term survival and cost benefit in ventilator-associated pneumonia and sepsis. Antimicrobial Agents and Chemotherapy 2016; 60: 3640-3646
13. Bauer M, Giamarellos-Bourboulis EJ, Kortgen A, Möller E, Felsmann K, Cavaillon JM, Guntinas-Lichius O, Rutschamnn O, Ruryk A, Kohl M, Wlotzka B, Ruβwurm S, Marshall JC, Reinhart K. A transcriptomic biomarker to quantify systemic inflammation in sepsis-a prospective multicenter phase II diagnostic study. EBioMedicine 2016; 6: 114-125
14. Giamarellos-Bourboulis EJ, Tziolos N, Routsi C, Katsenos C, Tsangaris I, Pneumatikos I, Vlachogiannis G, Theodorou V, Prekates A, Antypa E, Koulouras V, Kapravelos N, Gogos C, Antoniadou E, Mandragos K, Armaganidis A. Improving outcomes of severe infections by multidrug-resistant pathogens with polyclonal IgM-enriched immunoglobulins. Clinical Microbiology and Infection 2016; 22: 499-506
15. Sponholz C, Kramer M, Schöneweck F, Menzel U, Rahatloo KI, Giamarellos-Bourboulis EJ, Papavassileiou V, Lymberopoulou K, Pavlaki M, Koutelidakis I, Perdios I, Scherag A, Bauer M, Platzer M, Huse K. Polymorphisms of the cystathionine beta-synthase gene are associated with susceptibility to sepsis. European Journal of Human Genetics 2016; 24: 1041-1048
16. Neugebauer S, Giamarellos-Bourboulis EJ, Pelekanou A, Marioli A, Baziaka F, Tsangaris I, Bauer M, Kiehntopf M. Metabolite profile in sepsis developing prognostic tools based on the type of infection. Critical Care Medicine 2016; 44: 1649-1662
17. Luo T, Krüger T, Knüpfer U, Kasper L, Wielsch N, Hube B, Kortgen A, Bauer M, Giamarellos-Bourboulis EJ, Dimopoulos G, Brakhage AA, Kniemeyer O. Immunoproteomic analysis of antibody responses to extracellular proteins of Candida albicans revealing the importance of glycosylation for antigen recognitions. Journal of Proteome Research 2016; 15: 2394-2406
18. Scherag A, Schöneweck F, Kesselmeier M, Taudien S, Platzer M, Felder M, Sponholz C, Tauranen A, Hill ASV, Hinds CJ, Hossain H, Suttorp N, Kurzai O, Slevogt H, Giamarellos-Bourboulis EJ, Armaganidis A, Trips E, Scholz M, Brunkhorts FM. Genetic factors of the disease course after sepsis: a genome-wide association study for 28 day mortality. EBioMedicine 2016; 12: 239-246
19. Mandragos E, Pistiki A, Tsangaris I, Routsi C, Paraschos M, Droggiti DI, Savvidou O, Mastrokalos D, Papagelopoulos PJ, Netea MG, Giamarellos-Bourboulis EJ. Survival after multiple traumas is associated with improved outcomes from gram-negative sepsis: clinical and experimental evidence. Journal of Infection 2017; 74: 163-171
20. Giamarellos-Bourboulis EJ, Tsaganos T, Tsangaris I, Lada M, Routsi C, Sinapidis D, Koupetori M, Bristianou M, Adamis G, Mandragos K, Dalekos G, Kritselis I, Giannikopoulos G, Koutelidakis I, Pavlaki M, Antoniadou E, Vlachogiannis G, Koulouras V, Prekates A, Dimopoulos G, Koutsoukou A, Pneumatikos I, Ioakeimidou A, Kotanidou A, Orfanos S, Armaganidis A, Gogos C. Validation of the new sepsis-3 definitions: proposal for improvement in early risk identification. Clinical Microbiology and Infection 2017; 23: 104-109
21. Antonakos N, Tsaganos T, Oberle V, Tsangaris I, Lada M, Pistiki A, Machairas N, Souli M, Bauer M, Giamarellos-Bourboulis EJ. Decreased cytokine production by mononuclear cells after severe Gram-negative infections: early clinical signs and association with final outcome. Critical Care 2017; 21: 48
22. Ioakeimidou A, Paggalou E, Kontogiorgi M, Antoniadou E, Kaziaki K, Psaroulis K, Giamarellos-Bourboulis EJ, Prekates A, Antonakos A, Lassale P, Gogos C. Incerase of circulating endocan over sepsis follow-up is associated with progression into organ dysfunction. European Journal of Clinical Microbiology and Infectious Diseases 2017, 36: 1749-1756
23. Kyriazopoulou K, Leventogiannis K, Norrby-Teglund A, Dimopoulos G, Pantazi A, Orfanos SE, Rovina N, Tsangaris I, Gkavogianni T, Botsa E, Chassiou E, Kotanidou A, Kontouli C, Chaloulis P, Velissaris D, Davva A, Sundén-Cullberg J, Akinosoglou K, Gogos A, Armaganidis A, Giamarellos-Bourboulis EJ. Macrophage activation-like syndrome: an immunological entity associated with rapid progression to death in sepsis. BMC Medicine 2017, 15-172
24. Christodoulou S, Kyriazopoulou E, Chrysanthakopoulou M, Karlis I, Karampela I, Gkizeli K, Veliki N, Safarika A, Giamarellos-Bourboulis EJ, Adamis G. Lipid peroxidation in Gram-negative bacteremia modulates the risk for septic shock and infections by resistant Klebsiella pneumoniae. European Journal of Clinical Microbiology and Infectious Diseases 2017, 36: 2171-2177
25. Akinosoglou K, Theodoraki S, Xanthopoulou I, Perperis A, Gkavogianni T, Pistiki A, Giamarellos-Bourboulis E, Gogos CA. Platelet reactivity in sepsis syndrome: results from the PRESS study. European Journal of Clinical Microbiology anf Infectious Diseases 2017, 36: 2503-2512
26. Retsas T, Huse K, Lazaridis LD, Karampela N, Bauer M, Paltzer M, Kolonia V, Papageorgiou E, Giamarellos-Bourboulis EJ, Dimopoulos G. Haplotypes composed of minor frequency alleles of the TNF gene protect from progression into sepsis: a study using the new sepsis classification. International Journal of Infectious Diseases 2018, 67: 102-106
Financial support to the conduct of PhD

The HISS has provided financial support to the conduct of 12 PhD theses. These PhD theses are based on the following publications (the name of the PhD student is highlighted in bold):

1. Carrer DP, Samonis G, Droggiti DI, Tsaganos T, Pistiki A, Giamarellos-Bourboulis EJ. Intravenous itraconazole against experimental Candida parapsilosis infection: efficacy after suppression of bacterial translocation. Journal of Infection and Chemotherapy 2013; 19: 1080-1086
2. Katsaris MP, Adamis T, Pistiki A, Carrer DP, Galani I, Sabracos L, Droggiti DI, Georgitsi M, Damoraki G, Giamarellos-Bourboulis EJ, Chrisofos M. Immunomodulatory intervention with interferon-γ in Escherichia coli pyelonephritis. Journal of Urology 2014; 192: 600-606
3. Polyzou E, Evangelinakis NE, Pistiki A, Kotsaki A, Siristatidis CA, Chrelias CC, Salamalekis E, Kassanos DP, Giamarellos-Bourboulis EJ. Angiopoietin-2 primes infection-induced preterm delivery. PLoS ONE 2014; 9: e86523
4. Chounta A, Ellinas C, Tzanetakou V, Pliarhopoulou F, Mplani C, Oikonomou A, Leventogiannis K, Giamarellos-Bourboulis EJ. Serum soluble urokinase plasminogen actvator receptor as a screening tool for the early diagnosis of hepatocellular carcinoma. Liver International 2015; 35: 601-607
5. Kanni T, Tzanetakou V, Savva A, Kertsen B, Pistiki A, van de Veerdonk, Netea MG, van der Meer JW, Giamarellos-Bourboulis EJ. Compartmentalized cytokine responses in hidradenitis suppurativa. PLoS ONE 2015; 10: e0130522
6. Paraschos MD, Patrani M, Pistiki A, Katsenos C, Tsaganos T, Netea MG, Giamarellos-Bourboulis EJ, Mandragos K. Defective cytokine production early after multiple traumas: modulation in severe sepsis. Cytokine 2015; 76: 222-226
7. Pantelidou IM, Galani E, Georgitsi M, Daikos GL, Giamarellos-Bourboulis EJ. Interactions of Klebsiella pneumoniae with the innate immune system vary in relation to clone and resistance phenotype. Antimicrobial Agents and Chemotherapy 2015; 59: 7036-7043
8. Pistiki A, Tsaganos T, Galani I, Giamarellos-Bourboulis EJ. In vitro activity of oral cephalosporins (cefprozil and cefixime) against ciprofloxacin-resistant enterobacteriaceae from community-acquired urinary-tract infections. Infectious Diseases and Therapy 2015, 4: 425-432
9. Tzanetakou V, Kanni T, Giatrakou S, Katoulis A, Papadavid E, Netea MG, Dinarello CA, van der Meer JWM, Rigopoulos D, Giamarellos-Bourboulis EJ. Safety and efficacy of anakinra in severe hidradenitis suppurativa: a randomized controlled trial. JAMA Dermatology 2016; 152: 52-59
10. Giamarellos-Bourboulis EJ, Platzer M, Karagiannidis I, Kanni T, Nikolakis G, Ulrich J, Bellutti M, Gollnick H, Bauer M, Zouboulis CC, Huse K. High copy numbers of β-defensin cluster on 8p23.1, confer genetic susceptibility, and modulate the physical course of hidradenitis suppurativa/acne inversa. Journal of Investigative Dermatology 2016, 136: 1592-1598
11. Maravitsa P, Adamopoulou M, Pistiki A, Netea MG, Louis K, Giamarellos-Bourboulis EJ. Systemic over-release of interleukin-17 in acute kidney injury after septic shock: clinical and experimental evidence. Immunology Letters 2016, 178: 68-76
12. Patrani M, Tsaganos T, Kotzampassi K, Paraschos M, Katsenos C, Giamarellos-Bourboulis EJ, Mandragos K. Soluble urokinase plasminogen activator receptor informs on the progression course after multiple injuries. Biomarkers 2016, 21: 660-664
13. Pistiki A, Tsaganos T, Tsangaris I, Antonakos N, Damoraki G, Giamarellos-Bourboulis EJ. Change of annexin binding of monocytes as an expression of cellular response to Candida albicans: down-regulation in severe sepsis. European Journal of Clinical Microbiology and Infectious Diseases 2016, 35: 178-1793
14. Chatzianastasiou A, Bibli SI, Andreadou I, Efentakis P, Kaludercic N, Wood ME, Whiteman M, Di Lisa F, Daiber A, Manolopoulos VG, Szabó C, Papapetropoulos A. Cardioprotection by H2S donors: nitric oxide-dependent and –independent mechanisms. Journal of Pharmacology and Experimental Therapeutics 2016; 358: 431-440
Organization and conduct of interventional and non-interventional studies in Sepsis

The HISS has acted as a Clinical Research Organization for four studies that have been completed and is currently acting as a Clinical Research Organization for five studies that are ongoing. The HISS is ELOT ΕΝ ISO 9001:2015 (registration number GR-QA-C-1865/17) certified for the conduct of randomized clinical trials in Greece. The certification is coming by EBETAM-MIRTEC S.A. that is an IQNet Partner. The certification comprises the ability for management, running, monitoring and reporting of a clinical trial through interaction with the Greek regulatory authority.

THE AIDA STUDY (completed study)

The AIDA consortium is a European Consortium funded by the Seventh Framework Program of the EU to run three randomized clinical trials in different infectious diseases aiming to prove that old and cheap antimicrobials remain equally active to newer and more expensive antimicrobials. The Work Package 2 of the AIDA was run by the HISS through collaboration with Micron Research Ltd.

Study title: “A prospective, open label, randomized controlled clinical trial, with pharmacokinetic-pharmacodynamic validation, to compare antimicrobial treatment with oral minocycline plus rifampicin to treatment with oral linezolid for complicated skin and skin structure infections (cSSSI) caused by methicillin-resistant Staphylococcus aureus (MRSA)”.
EudraCT number: 2014-001276-56 National Organization for Medicines Approval: IS-83/14
National Ethics Committee Approval: 87/14
Duration: November 2014 and December 2016
Study phase: IV
Number of Study sites: 17
Total number of enrolled patients: 122
Site Hospital PI Enrolled pts
Dpt of Internal Medicine Argos Hospital G. Mavras & I. Kritselis 14
1st Dpt of Internal Medicine “G.Gennimatas” General Hospital P. Gargalianos 2
Dpt of Plastic Surgery - “G.Gennimatas” General Hospital D. Tsoutsos 6
1st Dpt of Internal Medicine “Evangelismos” General Hospital E. Kokkinakis 0
3rd Dpt of Internal Medicine “Evangelismos” General Hospital T. Kontopoulou 48
1st Dpt of Internal Medicine Thriasion General Hospital S. Symbardi 10
2nd Dpt of Internal Medicine Thriasion General Hospital Z. Alexiou 11
2nd Dpt of Internal Medicine Ippokration General Hospital H. Sambatakou 2
2nd Department of Surgery Ippokration General Hospital K. Toutouzas 6
Dpt of Internal Medicine University General Hospital of Patra C. Gogos 3
2nd Dpt of Internal Medicine Sismanoglion General Hospital E. Dimitrellos 5
1st Dpt of Internal Medicine University General Hospital of Thessaloniki AHEPA S. Metallidis 0
2nd Dpt of Surgery G. Gennimatas General Hospital of Thessaloniki I. Koutelidakis 7
Dpt of Internal Medicine KAT General Hospital M. Lelekis 0
3rd Dpt of Internal Medicine Korgialenio-Benakeion General Hospital M. Lazanas 0
3rd Dpt of Internal Medicine Sotiria General Hospital of Chest Diseases K.Syrigos 0
Dpt of Internal Medicine Lamia General Hospital M.Bristianou 7

THE SPECIFY STUDY (completed study)

The SPECIFY study is a non-interventional study aiming to develop a complex score composed by clinical data, genomic data and protein biomarkers to early predict patients with infection by Clostridium difficile at high likelihood to develop organ failure, relapse of the infection or die.

Study title::“Scoring PErsonalized needs in Clostridium difficile Infections for Fidaxomixin therapY”.
ClinicalTrials.gov NCT02573571
Duration: September 2015 to December 2016
Study phase: II
Number of Study sites: 11
Total number of enrolled patients: 153
Study site PI Enrolled pts
5th Department of Internal Medicine, Evangelismos General Hospital A.Skoutelis 31
4th Department of Internal Medicine, Attikon university Hospital E.Giamarellos 29
1st Department of Internal Medicine, G. Gennimatas General Hospital P.Gargalianos 21
1st Department of Internal Medicine, Thriasion General Hospital S.Symbardi 20
Department of Infectious Diseases, Tzaneio General Hospital G. Chrysos 19
2nd Department of Internal Medicine, Thriasion General Hospital Z. Alexiou 17
3rd Department of Internal Medicine, Sotiria General Hospital K. Syrigos 6
1st Department of Internal Medicine, Laiko General Hospital G. Daikos 4
1st Department of Internal Medicine, AHEPA University Hospital of Thessaloniki S. Metallidis 3
2nd Department of Internal Medicine, Sismanogleio General Hospital M. Lada 2
Department of Internal Medicine, University Hospital of Patras C. Gogos 1

THE INTELLIGENCE-1 STUDY (completed)

INTELLIGENCE-1 is a non-interventional trial to validate the diagnostic accuracy of HemoSpec in the diagnosis of sepsis. HemoSpec is a device that integrates information of whole blood cell count, Raman spectra of circulating white blood cells and serum proteins.

Study title: “INTEgration of clinicaL and Laboratory Information to GENerate technological advanCE for the diagnosis of sepsis”
ClinicalTrials.gov NCT03306186
Duration: October 2017-March 2018
Study phase: II
Study sites: 5 sites in Greece
Enrolled patients: 173
Study site PI Enrolled pts
4th Department of Internal Medicine, Attikon university Hospital E.Giamarellos 145
1st Department of Propeceudic Surgery, Hippokrateoin Athens General Hospital K.Toutouzas 7
Intensive Care Unit, Hippokrateion Athens General Hospital S.Karatzas 13
Intensive Care Unit, Konstantopouleion Athens General Hospital S.Mathas 1
Intensive Care Unit, Tzaneion Piraeus General Hospital A.Prekates 7

THE ACTIVATE STUDY (running)

ACTIVATE is a randomized clinical trial aiming to investigate if the developing concept of trained immunity i.e. the memory of the innate immune system coming after vaccination exists in humans and may lead to protection from infections.

Study title: “A randomized Clinical Trial for enhanced trained Immune responses through bacillus calmette-guérin VAccination to prevenT infections of the Elderly”
ClinicalTrials.gov NCT03306186
EudraCT number 2017-000596-87
National Ethics Committee approval: 27/17
Study phase: II
Study sites: one site in Greece
Target of enrolment: 200 patients
Actual start month: October 2017
Anticipated end month: December 2019
Current enrolment state: 62 patients

THE INCLASS STUDY (running)

INCLASS is a randomized clinical trial aiming to compare the efficacy of intravenous clarithromycin over placebo in patients with sepsis and respiratory failure.

Study title: “A double-blind, randomized, placebo-controlled clinical study of the efficacy of INtravenous CLArithromycin as adjunctive treatment in patients with Sepsis and respiratory and multiple organ dysfunction Syndrome”
ClinicalTrials.gov NCT03296423
EudraCT number 2017-001056-55
National Organization for Medicines Approval: IS-64/17
National Ethics Committee Approval: 64/17
Study phase: IV
Study sites: 9 sites in Greece and in 4 sites in Belgium
Target of enrolment: 110 patients
Actual start date: January 2018
Current enrolment state: 29 patients

THE PROGRESS STUDY (running)

PROGRESS is a randomized clinical trial aiming to test the efficacy of an algorithm of the duration of antimicrobial treatment based on serum procalcitonin in patients with sepsis on the development of resistant bowel microbiota and of infections by Clostriidium difficile.

Study title: “A randomized prospective clinical trial to assess the role of PROcalcitonin-Guided antimicrobial therapy to REduce long-term infectionS Sequelae”
ClinicalTrials.gov NCT03333304
EudraCT number 2017-002011-33
National Organization for Medicines Approval: IS-62/17
National Ethics Committee Approval: 62/17
Study phase: II
Study sites: 5 sites in Greece
Target of enrolment: 280 patients
Actual start month: October 2017
Anticipated end month: June 2019
Current enrolment state: 125 patients

THE PROVIDE STUDY (running)

PROVIDE is a randomized clinical trial aiming to the personalized therapy of patients at septic shock. Using biomarkers, enrolled patients are randomized through a double-dummy approach to immunotherapy or placebo treatment. Immunotherapy could be either anakinra or recombinant human interferon-gamma; enrolment and randomization is based on their laboratory immune profile

Study title: “A Personalized Randomized Trial of Validation and Restoration of Immune Dysfunction in Severe Infections and Sepsis”
ClinicalTrials.gov NCT03332225
EudraCT number 2017-002011-33
National Organization for Medicines Approval: IS-78/17
National Ethics Committee Approval: 78/17
Study phase: II
Study sites: 11 sites in Greece
Target of enrolment: 278 patients
Actual start month: December 2017
Anticipated end month: December 2019
Current enrolment state: 12 patients

THE PROMT STUDY (running)

PROMPT is a non-interventional trial to validate the diagnostic accuracy of Heparin Binding Protein for patients admitted in the emergency department in the diagnosis of sepsis and short-outcome prognosis

Study title: “Prospective Multi-centre Clinical Study to Assess the Clinical Validity of the Heparin Binding Protein Assay to Indicate the Presence and Outcome of Sepsis in Patients With Suspected Infection Following Emergency Department Admission”
ClinicalTrials.gov NCT03295825
Study phase: II
Study sites: 6 sites in Greece
Target of enrolment: 400 patients
Actual start month: November 2017
Anticipated end month: June 2019
Current enrolment state: 380 patients
Organization and conduct of interventional studies in Hidradenitis Suppurativa

Why Hidradenitis Suppurativa (HS)?

HS is a chronic inflammatory skin disorder that affects skin areas rich in apocrine glands. HS starts at early adolescence and it is affecting almost 1% of the general population. HS is characterized by exacerbations of heavy inflammation associated with extreme pain and limb and social disability. The Executive Board of the HISS decided to support research activity in HS when data generated from the Out-Patients Department of Immunology of Infections of ATTIKON University Hospital showed that circulating white blood cells of patients with HS share common functional characteristics with sepsis patients thus making HS a study prototype of systemic inflammation.

Interventional Studies supported by the HISS

A double-blind, randomised, placebo-controlled clinical trial of the safety and efficacy of anakinra in patients with hidradenitis suppurativa study code HIDRA03, IS 92/11 permission by the National Organization for Medicines, 100/11 permission by the National Ethics Committee, EudraCT number 2011-005145-12, www.clinicaltrials.gov NCT: 01558375, phase 2 interventional study in two sites (enrolled patients 19)
An open label Phase II trial in patients with moderate to severe hidradenitis suppurativa to evaluate the safety of IFX-1 study code IFX-1-P2.3, IS 90/16 permission by the National Organization for Medicines, 92/16 permission by the National Ethics Committee, EudraCT number 2016-002988-33, www.clinicaltrials.gov NCT: 01558375, phase 2 interventional study in one site (enrolled patients 12)

THE PROVIDE STUDY (running)

PROVIDE is a randomized clinical trial aiming to the personalized therapy of patients at septic shock. Using biomarkers, enrolled patients are randomized through a double-dummy approach to immunotherapy or placebo treatment. Immunotherapy could be either anakinra or recombinant human interferon-gamma; enrolment and randomization is based on their laboratory immune profile

Study title: “A Personalized Randomized Trial of Validation and Restoration of Immune Dysfunction in Severe Infections and Sepsis”
ClinicalTrials.gov NCT03332225
EudraCT number 2017-002011-33
National Organization for Medicines Approval: IS-78/17
National Ethics Committee Approval: 78/17
Study phase: II
Study sites: 11 sites in Greece
Target of enrolment: 278 patients
Actual start month: December 2017
Anticipated end month: December 2019
Current enrolment state: 12 patients

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Hellenic Institute for the Study of Sepsis

88 Michalakopoulou Street, 11528 Athens, Greece
Tel/Fax: +302107480662

e-mail: insepsis@otenet.gr