Safety and Efficacy Study of Recombinant Human Lactoferrin to Treat Severe Sepsis

Completed · Phase 2 · Has a placebo group

Conditions studied: Severe Sepsis

In brief

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

Key facts

Study ID

NCT00630656

Run by

Agennix

People needed

190

Starts

2008-04-01

Expected to finish

2010-02-01

Last updated by the study team

2011-08-23

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, legal next-of-kin or legal guardian
• Able to take 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
• Patient, legal representative or patient's primary physician not committed to providing full, aggressive life support

Where it is running

• 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

Full record on ClinicalTrials.gov

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