Safety and Efficacy Study of Recombinant Human Lactoferrin to Treat Severe Sepsis
- Registration Number
- NCT00630656
- Lead Sponsor
- Agennix
- Brief Summary
Study will evaluate the safety and potential benefit of recombinant human talactoferrin as an addition to the standard care of severe sepsis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 190
- 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, legal next-of-kin or legal guardian
- Able to take 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
- 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 2 Placebo Placebo 1 Talactoferrin alfa Talactoferrin alfa
- Primary Outcome Measures
Name Time Method All-cause mortality 28-day
- Secondary Outcome Measures
Name Time Method All-cause mortality 6 months
Trial Locations
- Locations (34)
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Kingston General Hospital
🇨🇦Kingston, Ontario, Canada
University of Pittsburgh Medical Center Presbyterian Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Centre Hospitalier de Montauban
🇫🇷Montauban, France
Hospital de Sabadell
🇪🇸Sabadell, Cataluña, Spain
Centre Hospitalier Angouleme
🇫🇷Saint-Michel, France
Vancouver General Hospital
🇨🇦Vancouver, British Columbia, Canada
Helios Klinikum Erfurt
🇩🇪Erfurt, Germany
Hospital Mutua de Terrassa
🇪🇸Terrassa, Cataluña, Spain
Texas Tech University Health Sciences Center
🇺🇸El Paso, Texas, United States
Ben Taub General Hospital
🇺🇸Houston, Texas, United States
Olive View- UCLA Medical Center
🇺🇸Sylmar, California, United States
Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
Denver Health Medical Center
🇺🇸Denver, Colorado, United States
The George Washington University Hospital
🇺🇸Washington, District of Columbia, United States
West Suburban Medical Center
🇺🇸Oak Park, Illinois, United States
Floyd Memorial Hospital and Health Services
🇺🇸New Albany, Indiana, United States
University of Iowa Hospitals and Clinic
🇺🇸Iowa City, Iowa, United States
St. Louis University
🇺🇸St. Louis, Missouri, United States
St. John's Mercy Medical Center
🇺🇸St. Louis, Missouri, United States
Cooper University Hospital
🇺🇸Camden, New Jersey, United States
Scott & White Memorial Hospital
🇺🇸Temple, Texas, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
The Methodist Hospital
🇺🇸Houston, Texas, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
University of Oklahoma Health Science Center
🇺🇸Oklahoma City, Oklahoma, United States
Intermountain Medical Center
🇺🇸Salt Lake City, Utah, United States
The University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
UC Davis Medical Center
🇺🇸Sacramento, California, United States
Wake Forest University Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
Baystate Medical Center
🇺🇸Springfield, Massachusetts, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States