A study with two regimes of CytoFab™ in Adult Patients With Severe Sepsis and/or Septic Shock

• Conditions: MedDRA version: 14.1Level: PTClassification code 10040047Term: SepsisSystem Organ Class: 10021881 - Infections and infestations; Severe sepsis and/or septic shock; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2009-015168-32-FI
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-02
• Last Update Posted: 7 August 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Adults with a first episode of sepsis during this hospitalisation.
2. Objective evidence of infection that requires parenteral antibiotics.
3. At least 2 of 4 SIRS criteria in the 24 hours before organ dysfunction (must include either fever OR elevated white blood cells [WBC]).
4. Cardiovascular or respiratory dysfunction.

Note: complete details are listed in Section 5.1 of the protocol.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

Exclusion Criteria

1. Moribund (not likely to survive 24 hours) or significant comorbidities making survival for 3 months unlikely.
2. Immunocompromising comorbidities or concomitant medications.
•Advanced human immunodeficiency virus (HIV) infection (CD4 =50/mm3).
•Stage III or IV cancer.
•Haemopoietic or lymphoreticular malignancies not in remission.
•Receiving radiation therapy or chemotherapy.
•Stem cell, organ or bone marrow transplant in the past 6 months.
•Absolute neutrophil count <500 per µL.
•Doses of some steroids and some immunocompromising drugs.
3. Concomitant diseases:
•Deep seated fungal infection or active tuberculosis.
•Cirrhosis with portal hypertension or Childs-Pugh Class C.
•History of chronic hypercarbia, respiratory failure in past 6 months or use of home oxygen in the setting of severe chronic respiratory disease.
•Neuromuscular disorders that impact breathing/spontaneous ventilation.
•Quadriplegia.
•Cardiac arrest in the past 30 days.
•New York Heart Association functional Class IV due to heart failure or any disorder.
•Burns over > 30% of body surface area.
4. Medication and allergy disqualifications.
•Treatment with anti-TNF agents within the last 8 weeks.
•Previously received ovine derived products (CroFab™, DigiFab™).
•Sheep product allergy or allergy to latex, papain, chymopapain.
5. Pregnancy or plans to breast feed upon resolution of sepsis.

Note: complete details are listed in Section 5.2 of the protocol.

Study & Design

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