Treatment of Patients With Early Septic Shock and Bio-Adrenomedullin(ADM) Concentration > 70 pg/ml With ADRECIZUMAB

PHASE2CompletedINTERVENTIONAL
Enrollment

301

Participants

Timeline

Start Date

December 12, 2017

Primary Completion Date

December 20, 2019

Study Completion Date

December 20, 2019

Conditions
Septic Shock
Interventions
BIOLOGICAL

Adrecizumab

Single i.v. dose of 2 mg/kg (treatment arm A) or 4 mg/kg (treatment arm B)

BIOLOGICAL

Placebo

Single i.v. dose of placebo (control group)

Trial Locations (30)

1200

Clinique Universitaire Saint-Luc (UCL Bruxelles), Brussels

1340

Clinique St. Pierre, Intensive Care, Ottignies

2650

Antwerp University Hospital (UZA), Critical Care Medicine, Edegem

7100

Groupe Jolimont, Hospitalier de Jolimont, Haine-Saint-Paul

18057

Universitätsmedizin Rostock Klinik und Poliklinik für Anästhesiologie und Intensivtherapie, Rostock

20246

Universitätsklinikum Hamburg-Eppendorf Klinik für Intensivmedizin, Hamburg

37044

CHRU Bretonneau, Medecine Intensive Réanimation, Tours

44093

CHU de Nantes; Medicine Intensive Reanimation, Nantes

48149

Universitätsklinikum Münster Klinik für Anästhesiologie, operative Intensivmedizin und Schmerztherapie, Münster

49933

Medical Intensive Care Medicine, Centre hospital - universitaire, Angers

52074

Universitätsklinikum Aachen, Klinik für Operative Intensivmedizin, Aachen

63003

University Hospital of Clermont-Ferrand, Dept. of Perioperative Medicine, Clermont-Ferrand

67091

Nouvel Hopital Civil, Strasbourg

67200

Hôpital de Hautepierre , Hôpitaux Universitaires de Strasbourg, Unité de Réanimation Chirurgicale, Service d'Anesthésie-Réanimation Chirurgicale, Strasbourg

75010

Hôpital Lariboisière, Dept. d'Anesthesie, Paris

Hôpital Lariboisière, Réanimation Médicale et Traumatologique, Paris

Hôpital Saint-Louis, Service d'Anesthésie-Réanimation, Paris

75015

Hôpital Européen Georges Pompidou, Service d'Anesthésie-Réanimation Chirurgicale, Université Paris Descartes, Paris

85000

CHD-Vendée, La Roche-sur-Yon

87042

CHU de Limoges, Limoges

92118

Hopital Beaujon; Anesthesie Reanimation, Clichy

92700

AP-HP, Hopital Louis Mourier, Réanimation Médicale, Colombes

94270

Hôpital de Bicêtre, Service d'anesthésie-réanimation chirurgicale, Le Kremlin-Bicêtre

95107

CH Victor Dupouy, Argenteuil

07747

Universitätsklinikum Jena Klinik für Anästhesiologie und Intensivmedizin, Jena

6716 RP

Gelderse Vallei Hospital, Department of Intensive Care, Ede

7512 KZ

Medisch Spectrum Twente, Department of Intensive Care, Enschede

6401 CX

Zuyderland Medical Center, Department of Intensive Care, Heerlen

6525 GA

Radboud UMC Intensive Care, Nijmegen

6532 SZ

Canisius-Wilhelmina-Ziekenhuis (CWZ), Intensive Care, Nijmegen

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Adrenomed AG

INDUSTRY

NCT03085758 - Treatment of Patients With Early Septic Shock and Bio-Adrenomedullin(ADM) Concentration > 70 pg/ml With ADRECIZUMAB | Biotech Hunter | Biotech Hunter