Study Stopped
Data Safety Monitoring Board recommendation
Safety and Efficacy of Talactoferrin Alfa in Patients With Severe Sepsis
OASIS
OASIS: A Phase 2/3 Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Talactoferrin Alfa in Patients With Severe Sepsis
1 other identifier
interventional
1,280
10 countries
100
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2011
Typical duration for phase_2
100 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 7, 2011
CompletedFirst Posted
Study publicly available on registry
January 11, 2011
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedFebruary 3, 2012
February 1, 2012
2.6 years
January 7, 2011
February 2, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
All Cause Mortality
28 Days
Secondary Outcomes (4)
All Cause Mortality
3 months
All Cause Mortality
6 months
All Cause Mortality
12 months
Assess Safety and Tolerability
28 days
Study Arms (2)
Placebo
PLACEBO COMPARATORTalactoferrin alfa
EXPERIMENTALInterventions
15 mL of an oral solution of 100mg/mL (1.5 g) given 3 times a day for up to 28 days or until discharge from the intensive care unit
15 mL of oral solution of placebo given 3 times a day for up to 28 days or until discharge from the intensive care unit
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Agennixlead
Study Sites (100)
University of Alabama - Birmingham
Birmingham, Alabama, 35249, United States
Providence Hospital
Mobile, Alabama, 36608, United States
Maricopa Medical Center
Maricopa, Arizona, 85008, United States
St. Joseph Hospital
Orange, California, 92868, United States
Sharp Memorial Hospital
San Diego, California, 92123, United States
Stanford University Hospital
Stanford, California, 94305-5117, United States
UCLA Medical Center
Sylmar, California, 91342, United States
Denver Health Medical Center
Denver, Colorado, 80204, United States
Christiana Care Health Services
Newark, Delaware, 19718, United States
George Washington University Hospital
Washington D.C., District of Columbia, 20037, United States
Bay Area Chest Physicians
Clearwater, Florida, 33756, United States
Eastern Idaho Medical Consultants
Idaho Falls, Idaho, 83404, United States
West Suburban Hospital Medical Center
Oak Park, Illinois, 60302, United States
Peoria Pulmonary Associates
Peoria, Illinois, 61603, United States
Methodist Research Institute
Indianapolis, Indiana, 46202, United States
University of Iowa
Iowa City, Iowa, 52242, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
St. Johns Mercy Medical Center
St Louis, Missouri, 63141, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Cooper University Hospital
Camden, New Jersey, 08103, United States
Moses Cone Memorial Hospital
Greensboro, North Carolina, 27401, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27517, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
St. Vincent Mercy Medical Center
Toledo, Ohio, 43608, United States
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, 73104, United States
Cancer Institute, Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
University of Tennessee
Memphis, Tennessee, 38163, United States
Texas Tech Health Science Center
El Paso, Texas, 79905, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
LDS Hospital
Murray, Utah, 84157, United States
University of Wisconsin Medical School
Madison, Wisconsin, 53792, United States
Clinique Saint-Pierre
Ottignies, Ottignies, 1340, Belgium
Hôpitaux IRIS Sud
Brussels, 1050, Belgium
Hôpital Erasme
Brussels, 1070, Belgium
UZ Brussel
Brussels, 1090, Belgium
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
Ziekenhuis Oost-Limburg
Genk, 3600, Belgium
UZ Gent
Ghent, 9000, Belgium
CHU de Liège
Liège, 4000, Belgium
Centre Hospitalier de Dinant
Mons, 7000, Belgium
Cliniques Universitaires UCL de Mont-Godinne
Yvoir, 5530, Belgium
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9, Canada
Royal Jubilee Hospital
Victoria, British Columbia, V8R 1J8, Canada
St. Boniface General Hospital
Winnipeg, Manitoba, R2H 2A6, Canada
Health Sciences Centre
Winnipeg, Manitoba, R3A 1R9, Canada
Grace Hospital
Winnipeg, Manitoba, R3J 3M7, Canada
Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia, B3H 3A7, Canada
Kingston General Hospital
Kingston, Ontario, K7L 2V7, Canada
Windsor Regional Hospital
Windsor, Ontario, N8X 3V6, Canada
SMBD - Jewish General Hospital
Montreal, Quebec, H3T 1C5, Canada
Aalborg Sygehus
Aalborg, DK-9100, Denmark
Odense universitetshospital
Odense, DK-5000, Denmark
Hôpital Universitaire Dupuytren
Limoges, Limoges, 87042, France
Hôtel Dieu
Angers, 49933, France
Centre Hospitalier Victor Dupouy
Argenteuil, 95107, France
Centre Hospitalier Départemental La Roche sur Yon, Luçon, Montaigu - Les Oudaries
La Roche-sur-Yon, 85925, France
Hôpital Albert Michallon / La Tronche
La Tronche, 38700, France
Centre Hospitalier de Montauban
Montauban, 82013, France
Hôpital de la Source
Orléans, 45067, France
Hôpital Cochin
Paris, 75679, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
Hôpital de la Miletrie
Poitiers, 86021, France
Centre Hospitalier Angouleme
Saint-Michel, 16470, France
Hôpital Bretonneau
Tours, 37044, France
Charité - Universitätsmedizin Berlin
Berlin, 13353, Germany
Universitätsklinikum Bonn
Bonn, 53105, Germany
Helios Klinikum Erfurt
Erfurt, 99089, Germany
Klinikum der Johann-Wolfgang Goethe-Universität
Frankfurt am Main, 60590, Germany
Klinikum der Friedrich-Schiller-Universität Jena
Jena, 07747, Germany
Klinikum der Stadt Ludwigshafen gGmbH
Ludwigshafen, 67063, Germany
Klinikum Harlaching
München, 81545, Germany
Rambam Medical Center
Haifa, 31096, Israel
The Lady Davis Carmel Medical Center
Haifa, 34362, Israel
Shaare Zedek Medical Center
Jerusalem, 91031, Israel
Hadassah University Hospital Ein Kerem
Jerusalem, 91120, Israel
Western Galilee Hospital - Nahariya
Nahariya, 22100, Israel
Rabin Medical Center
Petah Tikva, 49100, Israel
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, 5223 GZ, Netherlands
VU Medisch Centrum
Amsterdam, 1081 HV, Netherlands
Gelre Ziekenhuizen
Apeldoorn, 7334 DZ, Netherlands
Medisch Centrum Leeuwarden
Leeuwarden, 8934 AD, Netherlands
UMC St. Radboud
Nijmegen, 6525 GA, Netherlands
Ikazia Ziekenhuis
Rotterdam, 3083 AN, Netherlands
Hospital del Mar
Barcelona, Catalonia, 08003, Spain
Hospital Universitari De Bellvitge
L'Hospitalet de Llobregat, Catalonia, 08907, Spain
Hospital de Sabadell
Sabadell, Catalonia, 8208, Spain
Hospital Universitari de Tarragona Joan XXIII
Tarragona, Catalonia, 43007, Spain
Hospital Mutua de Terrassa
Terrassa, Catalonia, 08221, Spain
Hospital Clinico San Carlos
Madrid, Madrid, Communidad de, 28040, Spain
Hospital Universitario La Paz
Madrid, Madrid, Communidad de, 28046, Spain
Hospital Universitario de Getafe
Getafe, 28905, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Aberdeen Royal Infirmary
Aberdeen, AB25 2ZN, United Kingdom
St James's University Hospital
Leeds, LS9 7TF, United Kingdom
St John's Hospital
Livingston, EH54 6PP, United Kingdom
University College London
London, NW1 2BU, United Kingdom
St. Thomas' Hospital
London, SE1 7EH, United Kingdom
Related Publications (1)
Vincent JL, Marshall JC, Dellinger RP, Simonson SG, Guntupalli K, Levy MM, Singer M, Malik R; Oral tAlactoferrin in Severe sepsIS Study Investigators. Talactoferrin in Severe Sepsis: Results From the Phase II/III Oral tAlactoferrin in Severe sepsIS Trial. Crit Care Med. 2015 Sep;43(9):1832-8. doi: 10.1097/CCM.0000000000001090.
PMID: 26010687DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2011
First Posted
January 11, 2011
Study Start
June 1, 2011
Primary Completion
January 1, 2014
Study Completion
December 1, 2014
Last Updated
February 3, 2012
Record last verified: 2012-02