Clinical trial NCT01273779: Safety and Efficacy of Talactoferrin Alfa in Patients With Severe Sepsis
Official title: OASIS: A Phase 2/3 Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Talactoferrin Alfa in Patients With Severe Sepsis
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
PHASE3
Conditions: Severe Sepsis
Keywords: sepsis
talactoferrin
lactoferrin
recombinant human lactoferrin
Lead sponsor: Agennix
Sponsor class: INDUSTRY
First posted: 2011-01-11
Enrollment: 1280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: All Cause Mortality
timeFrame: 28 Days
Secondary outcomes:
measure: All Cause Mortality
timeFrame: 3 months
measure: All Cause Mortality
timeFrame: 6 months
measure: All Cause Mortality
timeFrame: 12 months
measure: Assess Safety and Tolerability
timeFrame: 28 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama - Birmingham
state: Alabama
city: Mobile
country: United States
facility: Providence Hospital
state: Alabama
city: Maricopa
country: United States
facility: Maricopa Medical Center
state: Arizona
city: Orange
country: United States
facility: St. Joseph Hospital
state: California
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
city: Stanford
country: United States
facility: Stanford University Hospital
state: California
city: Sylmar
country: United States
facility: UCLA Medical Center
state: California
city: Denver
country: United States
facility: Denver Health Medical Center
state: Colorado
city: Newark
country: United States
facility: Christiana Care Health Services
state: Delaware
city: Washington
country: United States
facility: George Washington University Hospital
state: District of Columbia
city: Clearwater
country: United States
facility: Bay Area Chest Physicians
state: Florida
city: Idaho Falls
country: United States
facility: Eastern Idaho Medical Consultants
state: Idaho
city: Oak Park
country: United States
facility: West Suburban Hospital Medical Center
state: Illinois
city: Peoria
country: United States
facility: Peoria Pulmonary Associates
state: Illinois
city: Indianapolis
country: United States
facility: Methodist Research Institute
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: St. Louis
country: United States
facility: St. Johns Mercy Medical Center
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: Greensboro
country: United States
facility: Moses Cone Memorial Hospital
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Columbus
country: United States
facility: Riverside Methodist Hospital
state: Ohio
city: Toledo
country: United States
facility: St. Vincent Mercy Medical Center
state: Ohio
city: Oklahoma
country: United States
facility: University of Oklahoma Health Science Center
state: Oklahoma
city: Pittsburgh
country: United States
facility: Cancer Institute, Hillman Cancer Center
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Memphis
country: United States
facility: University of Tennessee
state: Tennessee
city: El Paso
country: United States
facility: Texas Tech Health Science Center
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Murray
country: United States
facility: LDS Hospital
state: Utah
city: Madison
country: United States
facility: University of Wisconsin Medical School
state: Wisconsin
city: Brussel
country: Belgium
facility: UZ Brussel
city: Bruxelles
country: Belgium
facility: Hôpitaux IRIS Sud
city: Bruxelles
country: Belgium
facility: Hôpital Erasme
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
city: Gent
country: Belgium
facility: UZ Gent
city: Liège
country: Belgium
facility: CHU de Liège
city: Mons
country: Belgium
facility: Centre Hospitalier de Dinant
city: Ottignies
country: Belgium
facility: Clinique Saint-Pierre
city: Yvoir
country: Belgium
facility: Cliniques Universitaires UCL de Mont-Godinne
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Victoria
country: Canada
facility: Royal Jubilee Hospital
state: British Columbia
city: Winnipeg
country: Canada
facility: St. Boniface General Hospital
state: Manitoba
city: Winnipeg
country: Canada
facility: Health Sciences Centre
state: Manitoba
city: Winnipeg
country: Canada
facility: Grace Hospital
state: Manitoba
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Center
state: Nova Scotia
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: Windsor
country: Canada
facility: Windsor Regional Hospital
state: Ontario
city: Montreal
country: Canada
facility: SMBD - Jewish General Hospital
state: Quebec
city: Aalborg
country: Denmark
facility: Aalborg Sygehus
city: Odense
country: Denmark
facility: Odense universitetshospital
city: Angers
country: France
facility: Hôtel Dieu
city: Argenteuil
country: France
facility: Centre Hospitalier Victor Dupouy
city: La Roche sur Yon
country: France
facility: Centre Hospitalier Départemental La Roche sur Yon, Luçon, Montaigu - Les Oudaries
city: La Tronche
country: France
facility: Hôpital Albert Michallon / La Tronche
city: Limoges
country: France
facility: Hôpital Universitaire Dupuytren
city: Montauban
country: France
facility: Centre Hospitalier de Montauban
city: Orléans
country: France
facility: Hôpital de la Source
city: Paris
country: France
facility: Hôpital Cochin
city: Pierre Benite
country: France
facility: Centre Hospitalier Lyon Sud
city: Poitiers
country: France
facility: Hôpital de la Miletrie
city: Saint-Michel
country: France
facility: Centre Hospitalier Angouleme
city: Tours
country: France
facility: Hôpital Bretonneau
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
city: Erfurt
country: Germany
facility: Helios Klinikum Erfurt
city: Frankfurt am Main
country: Germany
facility: Klinikum der Johann-Wolfgang Goethe-Universität
city: Jena
country: Germany
facility: Klinikum der Friedrich-Schiller-Universität Jena
city: Ludwigshafen
country: Germany
facility: Klinikum der Stadt Ludwigshafen gGmbH
city: München
country: Germany
facility: Klinikum Harlaching
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Haifa
country: Israel
facility: The Lady Davis Carmel Medical Center
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Jerusalem
country: Israel
facility: Hadassah University Hospital Ein Kerem
city: Nahariya
country: Israel
facility: Western Galilee Hospital - Nahariya
city: Petach Tikva
country: Israel
facility: Rabin Medical Center
city: 's-Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
city: Amsterdam
country: Netherlands
facility: VU Medisch Centrum
city: Apeldoorn
country: Netherlands
facility: Gelre Ziekenhuizen
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden
city: Nijmegen
country: Netherlands
facility: UMC St. Radboud
city: Rotterdam
country: Netherlands
facility: Ikazia Ziekenhuis
city: Barcelona
country: Spain
facility: Hospital del Mar
state: Cataluña
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari De Bellvitge
state: Cataluña
city: Sabadell
country: Spain
facility: Hospital de Sabadell
state: Cataluña
city: Tarragona
country: Spain
facility: Hospital Universitari de Tarragona Joan XXIII
state: Cataluña
city: Terrassa
country: Spain
facility: Hospital Mutua de Terrassa
state: Cataluña
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
state: Madrid, Communidad de
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
state: Madrid, Communidad de
city: Getafe
country: Spain
facility: Hospital Universitario de Getafe
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
city: Leeds
country: United Kingdom
facility: St James's University Hospital
city: Livingston
country: United Kingdom
facility: St John's Hospital
city: London
country: United Kingdom
facility: University College London
city: London
country: United Kingdom
facility: St. Thomas' Hospital
Study officials:
References:
citation: 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.