Safety and Efficacy Study of Recombinant Human Lactoferrin to Treat Severe Sepsis
NCT ID: NCT00630656
Last Updated: 2011-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
190 participants
INTERVENTIONAL
2008-04-30
2010-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Talactoferrin alfa
Talactoferrin alfa
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
2
Placebo
Placebo
Placebo given 3 times a day for up to 28 days or until discharge from the intensive care unit
Interventions
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Talactoferrin alfa
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
Placebo
Placebo given 3 times a day for up to 28 days or until discharge from the intensive care unit
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Agennix
INDUSTRY
Responsible Party
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Principal Investigators
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Kalpalatha K Guntupalli, MD
Role: PRINCIPAL_INVESTIGATOR
Baylor College of Medicine
Locations
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Loma Linda University Medical Center
Loma Linda, California, United States
UC Davis Medical Center
Sacramento, California, United States
Olive View- UCLA Medical Center
Sylmar, California, United States
Denver Health Medical Center
Denver, Colorado, United States
The George Washington University Hospital
Washington D.C., District of Columbia, United States
Rush University Medical Center
Chicago, Illinois, 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
University of Kansas Medical Center
Kansas City, Kansas, United States
Baystate Medical Center
Springfield, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, 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
Duke University Medical Center
Durham, North Carolina, 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
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, United States
University of Pittsburgh Medical Center Presbyterian Hospital
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Texas Tech University Health Sciences Center
El Paso, Texas, United States
Ben Taub General Hospital
Houston, Texas, United States
The Methodist Hospital
Houston, Texas, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Scott & White Memorial Hospital
Temple, Texas, United States
Intermountain Medical Center
Salt Lake City, Utah, United States
Vancouver General Hospital
Vancouver, British Columbia, Canada
Kingston General Hospital
Kingston, Ontario, Canada
Centre Hospitalier de Montauban
Montauban, , France
Centre Hospitalier Angouleme
Saint-Michel, , France
Helios Klinikum Erfurt
Erfurt, , Germany
Hospital de Sabadell
Sabadell, Catalonia, Spain
Hospital Mutua de Terrassa
Terrassa, Catalonia, Spain
Countries
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References
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Guntupalli K, Dean N, Morris PE, Bandi V, Margolis B, Rivers E, Levy M, Lodato RF, Ismail PM, Reese A, Schaumberg JP, Malik R, Dellinger RP; TLF LF-0801 Investigator Group. A phase 2 randomized, double-blind, placebo-controlled study of the safety and efficacy of talactoferrin in patients with severe sepsis. Crit Care Med. 2013 Mar;41(3):706-16. doi: 10.1097/CCM.0b013e3182741551.
Other Identifiers
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NIH grant 1R44GM077816-01A2
Identifier Type: -
Identifier Source: secondary_id
LF-0801
Identifier Type: -
Identifier Source: org_study_id
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