Safety and Efficacy of Talactoferrin Alfa in Patients With Severe Sepsis

Paused · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Severe Sepsis

In brief

Study will evaluate the safety and potential benefit of talactoferrin (recombinant human lactoferrin) as an addition to the standard care for severe sepsis.

Key facts

Study ID

NCT01273779

Run by

Agennix

People needed

1280

Starts

2011-06-01

Expected to finish

2014-12-01

Last updated by the study team

2012-02-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Providence Hospital — Mobile, Alabama, United States
• Maricopa Medical Center — Maricopa, Arizona, United States
• St. Joseph Hospital — Orange, California, United States
• Sharp Memorial Hospital — San Diego, California, United States
• Stanford University Hospital — Stanford, California, United States
• UCLA Medical Center — Sylmar, California, United States
• Denver Health Medical Center — Denver, Colorado, United States
• Christiana Care Health Services — Newark, Delaware, United States
• George Washington University Hospital — Washington D.C., District of Columbia, United States
• Bay Area Chest Physicians — Clearwater, Florida, United States
• Eastern Idaho Medical Consultants — Idaho Falls, Idaho, United States
• West Suburban Hospital Medical Center — Oak Park, Illinois, United States
• Peoria Pulmonary Associates — Peoria, Illinois, United States
• Methodist Research Institute — Indianapolis, Indiana, United States
• University of Iowa — Iowa City, Iowa, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Baystate Medical Center — Springfield, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• St. Johns Mercy Medical Center — St Louis, Missouri, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Cooper University Hospital — Camden, New Jersey, United States
• Moses Cone Memorial Hospital — Greensboro, North Carolina, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• Riverside Methodist Hospital — Columbus, Ohio, United States
• University of Alabama - Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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