A double-blind, randomized, placebo-controlled study to investigate the clinical efficacy and safety of two doses of Alkaline Phosphatase administered for three days in patients with severe sepsis and septic shock - AP SEP 02-02

• Conditions: Severe sepsis and septic shock

• Registration Number: EUCTR2006-000769-13-BE
• Lead Sponsor: AM-Pharma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05-08
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 960

Inclusion Criteria

Clinical defined sepsis:
•Proven or suspected bacterial infection and
•Minimally 2 out of 4 SIRS criteria of systemic inflammation positive:
Acute onset of at least 1 end-organ dysfunction in the preceding 36 hours:
•unrelated to the primary septic focus and
•not explained by any underlying primary chronic disease and
•as described by at least one of the following 7 underlying conditions:
1. Sustained hypotension
2. Acute renal failure
3. Acute alteration in mental state
4. Acute hypoxemic respiratory failure
5. Disseminated intravascular coagulopathy (DIC)
6. Metabolic acidosis
7. Acute hepatic failure
at least 18 years
Body weight = 125 kg
Being committed to - and treated with full intensive care support
Written informed consent obtained.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Patients being treated for transplantation of bone marrow, lung, liver, pancreas or other condition.
2.Known confirmed gram-positive sepsis.
3.Known confirmed fungal sepsis.
4.Chronic renal failure requiring hemodialysis or peritoneal dialysis.
5.Acute pancreatitis with no established source of infection.
6.Patients expected to have rapidly fatal disease within 24 hours .
7.Patients not expected to survive for 28 days, due to other medical conditions such as end-stage neoplasm or other diseases.
8.Patients being treated with cancer related chemotherapy.
9.Participation in another investigational study which clearly and documented interferes with this study, within 30 days prior to start of the study .
10.Previous administration of AP.
11.Allergy for cow milk.
12.Known HIV patients with CD4-count < 50.
13.Pregnant and lactating women.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified