Safety and Efficacy of Talactoferrin Alfa in Patients With Severe Sepsis
- Registration Number
- NCT01273779
- Lead Sponsor
- Agennix
- Brief Summary
Study will evaluate the safety and potential benefit of talactoferrin (recombinant human lactoferrin) as an addition to the standard care for severe sepsis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 1280
- Age greater than or equal to 18 years
- Onset of severe sepsis within the previous 24 hours
- Must be receiving antibiotic therapy
- Informed consent form signed by patient or authorized representatives according to local rules or regulations
- Able to take liquid medication by mouth or feeding tube
- Receipt of investigational medication within 4 weeks prior to participation in the study
- Pregnant or breast-feeding
- Severe congestive heart failure
- Known severe HIV infection
- Presence of severe burns
- Patients on high dose immunosuppressants
- Patients whose death is considered imminent
- Patients whose life expectancy for concurrent illness is less than 6 months
- Severe hypoxic encephalopathy or persistent vegetative state
- Severe liver disease
- Chronically bed bound
- Patient, legal representative or patient's primary physician not committed to providing full, aggressive life support
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Talactoferrin alfa Talactoferrin alfa - Placebo Placebo -
- Primary Outcome Measures
Name Time Method All Cause Mortality 28 Days
- Secondary Outcome Measures
Name Time Method All Cause Mortality 12 months Assess Safety and Tolerability 28 days
Trial Locations
- Locations (99)
Royal Jubilee Hospital
🇨🇦Victoria, British Columbia, Canada
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Methodist Research Institute
🇺🇸Indianapolis, Indiana, United States
Clinique Saint-Pierre
🇧🇪Ottignies, Belgium
UZ Brussel
🇧🇪Brussel, Belgium
CHU de Liège
🇧🇪Liège, Belgium
Cliniques Universitaires UCL de Mont-Godinne
🇧🇪Yvoir, Belgium
Vancouver General Hospital
🇨🇦Vancouver, British Columbia, Canada
Cliniques Universitaires Saint-Luc
🇧🇪Bruxelles, Belgium
UZ Gent
🇧🇪Gent, Belgium
Centre Hospitalier de Dinant
🇧🇪Mons, Belgium
Ziekenhuis Oost-Limburg
🇧🇪Genk, Belgium
Hôpitaux IRIS Sud
🇧🇪Bruxelles, Belgium
University College London
🇬🇧London, United Kingdom
Hôpital Bretonneau
🇫🇷Tours, France
University of Alabama - Birmingham
🇺🇸Birmingham, Alabama, United States
Sharp Memorial Hospital
🇺🇸San Diego, California, United States
Denver Health Medical Center
🇺🇸Denver, Colorado, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
University of Tennessee
🇺🇸Memphis, Tennessee, United States
Providence Hospital
🇺🇸Mobile, Alabama, United States
George Washington University Hospital
🇺🇸Washington, District of Columbia, United States
Bay Area Chest Physicians
🇺🇸Clearwater, Florida, United States
Odense universitetshospital
🇩🇰Odense, Denmark
Hôpital Cochin
🇫🇷Paris, France
Hôtel Dieu
🇫🇷Angers, France
Centre Hospitalier de Montauban
🇫🇷Montauban, France
Grace Hospital
🇨🇦Winnipeg, Manitoba, Canada
Windsor Regional Hospital
🇨🇦Windsor, Ontario, Canada
Kingston General Hospital
🇨🇦Kingston, Ontario, Canada
Centre Hospitalier Lyon Sud
🇫🇷Pierre Benite, France
Queen Elizabeth II Health Sciences Center
🇨🇦Halifax, Nova Scotia, Canada
Charité - Universitätsmedizin Berlin
🇩🇪Berlin, Germany
Hôpital de la Source
🇫🇷Orléans, France
Hôpital de la Miletrie
🇫🇷Poitiers, France
Centre Hospitalier Angouleme
🇫🇷Saint-Michel, France
Klinikum der Stadt Ludwigshafen gGmbH
🇩🇪Ludwigshafen, Germany
Rambam Medical Center
🇮🇱Haifa, Israel
The Lady Davis Carmel Medical Center
🇮🇱Haifa, Israel
Jeroen Bosch Ziekenhuis
🇳🇱's-Hertogenbosch, Netherlands
Medisch Centrum Leeuwarden
🇳🇱Leeuwarden, Netherlands
St. Thomas' Hospital
🇬🇧London, United Kingdom
Hospital de Sabadell
🇪🇸Sabadell, Cataluña, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Ikazia Ziekenhuis
🇳🇱Rotterdam, Netherlands
St John's Hospital
🇬🇧Livingston, United Kingdom
Hospital del Mar
🇪🇸Barcelona, Cataluña, Spain
Hospital Universitari de Tarragona Joan XXIII
🇪🇸Tarragona, Cataluña, Spain
Hospital Universitario de Getafe
🇪🇸Getafe, Spain
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
Maricopa Medical Center
🇺🇸Maricopa, Arizona, United States
St. Joseph Hospital
🇺🇸Orange, California, United States
UCLA Medical Center
🇺🇸Sylmar, California, United States
Christiana Care Health Services
🇺🇸Newark, Delaware, United States
Eastern Idaho Medical Consultants
🇺🇸Idaho Falls, Idaho, United States
Moses Cone Memorial Hospital
🇺🇸Greensboro, North Carolina, United States
Texas Tech Health Science Center
🇺🇸El Paso, Texas, United States
University of Wisconsin Medical School
🇺🇸Madison, Wisconsin, United States
Hôpital Erasme
🇧🇪Bruxelles, Belgium
St. Boniface General Hospital
🇨🇦Winnipeg, Manitoba, Canada
Health Sciences Centre
🇨🇦Winnipeg, Manitoba, Canada
SMBD - Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
Aalborg Sygehus
🇩🇰Aalborg, Denmark
Centre Hospitalier Victor Dupouy
🇫🇷Argenteuil, France
Hôpital Universitaire Dupuytren
🇫🇷Limoges, France
Hôpital Albert Michallon / La Tronche
🇫🇷La Tronche, France
Centre Hospitalier Départemental La Roche sur Yon, Luçon, Montaigu - Les Oudaries
🇫🇷La Roche sur Yon, France
Helios Klinikum Erfurt
🇩🇪Erfurt, Germany
Klinikum der Johann-Wolfgang Goethe-Universität
🇩🇪Frankfurt am Main, Germany
Klinikum Harlaching
🇩🇪München, Germany
Shaare Zedek Medical Center
🇮🇱Jerusalem, Israel
Western Galilee Hospital - Nahariya
🇮🇱Nahariya, Israel
Rabin Medical Center
🇮🇱Petach Tikva, Israel
Gelre Ziekenhuizen
🇳🇱Apeldoorn, Netherlands
VU Medisch Centrum
🇳🇱Amsterdam, Netherlands
UMC St. Radboud
🇳🇱Nijmegen, Netherlands
Hospital Universitari De Bellvitge
🇪🇸L'Hospitalet de Llobregat, Cataluña, Spain
Hospital Mutua de Terrassa
🇪🇸Terrassa, Cataluña, Spain
Hospital Clinico San Carlos
🇪🇸Madrid, Madrid, Communidad de, Spain
St James's University Hospital
🇬🇧Leeds, United Kingdom
Aberdeen Royal Infirmary
🇬🇧Aberdeen, United Kingdom
Baystate Medical Center
🇺🇸Springfield, Massachusetts, United States
Stanford University Hospital
🇺🇸Stanford, California, United States
University of Oklahoma Health Science Center
🇺🇸Oklahoma, Oklahoma, United States
West Suburban Hospital Medical Center
🇺🇸Oak Park, Illinois, United States
St. Johns Mercy Medical Center
🇺🇸St. Louis, Missouri, United States
Cancer Institute, Hillman Cancer Center
🇺🇸Pittsburgh, Pennsylvania, United States
Riverside Methodist Hospital
🇺🇸Columbus, Ohio, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
Cooper University Hospital
🇺🇸Camden, New Jersey, United States
Universitätsklinikum Bonn
🇩🇪Bonn, Germany
Hadassah University Hospital Ein Kerem
🇮🇱Jerusalem, Israel
Peoria Pulmonary Associates
🇺🇸Peoria, Illinois, United States
Klinikum der Friedrich-Schiller-Universität Jena
🇩🇪Jena, Germany
St. Vincent Mercy Medical Center
🇺🇸Toledo, Ohio, United States
LDS Hospital
🇺🇸Murray, Utah, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States