Severe Sepsis
Conditions
Keywords
sepsis, talactoferrin, lactoferrin, recombinant human lactoferrin
Brief summary
Study will evaluate the safety and potential benefit of recombinant human talactoferrin as an addition to the standard care of severe sepsis.
Interventions
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
DRUGPlacebo
Placebo given 3 times a day for up to 28 days or until discharge from the intensive care unit
Sponsors
Agennix
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality | 28-day |
Secondary
| Measure | Time frame |
|---|---|
| All-cause mortality | 3 months |
Countries
Canada, France, Germany, Spain, United States
Outcome results
None listed