Bovine Intestinal Alkaline Phosphatase for the Treatment of Patients With Sepsis

• Status: Completed
• Trial end date: 2006-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Eligible patients will receive either AP or matching placebo in a double blind, randomized design and following a 2:1 ratio. All medication will be given in addition to standard care for sepsis patients. Patients will be followed for 28 days after the start of study medication administration. A blinded safety review of the study results will take place after the inclusion of 12 patients in the study.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AM-Pharma

Criteria

Inclusion Criteria:

• Patients between 18 and 80 years (inclusive);

• proven or suspected infection;

• meeting 2 of 4 of the systemic inflammatory response syndrome (SIRS) criteria;

• septic shock or one or more acute organ failures in the preceding 12 hours;

• written informed consent obtained.

Exclusion Criteria:

• Pregnant or lactating women;

• known HIV seropositive patients;

• patients receiving immunosuppressive therapy or chronically using high doses of glucocorticosteroids (defined as > 1 mg/kg/day) equivalent to prednisone 1 mg/kg/day;

• patients expected to have rapidly fatal disease within 24 h;

• known confirmed gram-positive sepsis;

• known confirmed fungal sepsis;

• chronic renal failure requiring haemodialysis or peritoneal dialysis;

• acute pancreatitis with no established source of infection;

• patients not expected to survive for 28 days due to other medical conditions such as end-stage neoplasm or other diseases;

• participation in another investigational study within 90 days prior to start of the study which might interfere with this study;

• previous administration of AP;

• known allergy for cow milk.