Status:
COMPLETED
Safety and Efficacy Study of Recombinant Human Lactoferrin to Treat Severe Sepsis
Lead Sponsor:
Agennix
Conditions:
Severe Sepsis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Study will evaluate the safety and potential benefit of recombinant human talactoferrin as an addition to the standard care of severe sepsis.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT00630656
Start Date
April 1 2008
End Date
February 1 2010
Last Update
August 23 2011
Active Locations (34)
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1
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
2
UC Davis Medical Center
Sacramento, California, United States, 95817
3
Olive View- UCLA Medical Center
Sylmar, California, United States, 91342
4
Denver Health Medical Center
Denver, Colorado, United States, 80204