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A Study to Compare the Efficacy and Safety of 2 Dosing Regimens of IV Infusions of AZD9773 (CytoFab™) With Placebo in Adult Patients With Severe Sepsis and/or Septic Shock

This study has been completed.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: June 7, 2010
Last updated: September 26, 2014
Last verified: September 2014
The primary purpose of this study to evaluate the effect of two different doses of AZD9773 (CytoFab™) versus placebo on ventilator free days (VFDs) over the first 28 days after the start of dosing with AZD9773 in patients with severe sepsis and/or septic shock, who are already receiving appropriate standard of care treatment for sepsis.

Condition Intervention Phase
Severe Sepsis
Septic Shock
Drug: AZD9773
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A MultiCentre, Randomized, Double-blind, Placebo-controlled Phase IIb Study to Compare the Efficacy and Safety of Two Dosing Regimens of Intravenous Infusions of AZD9773 (CytoFab™) in Adult Patients With Severe Sepsis and/or Septic Shock

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Ventilator-free Days (VFDs) Over 28 Days [ Time Frame: Over 28 days following first dose ]
    Number of ventilator-free days (VFDs)

Secondary Outcome Measures:
  • 7-day Mortality [ Time Frame: Over 7 days following first dose ]
    Number of patients who died over 7 days

  • 28-day Mortality [ Time Frame: Over 28 days following first dose ]
    Number of patients who died over 28 days

  • Safety and Tolerability [ Time Frame: All study visits (over 90 days following first dose) ]
    Number of patients with treatment-emergent adverse events

Enrollment: 300
Study Start Date: October 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
AZD9773 250/50 units/kg
Drug: AZD9773
A single loading dose following by up to 9 maintenance doses; doses to be given every 12 hours over a period of 5 days
Other Name: CytoFab™
Experimental: 2
AZD9773 500/100 units/kg
Drug: AZD9773
A single loading dose following by up to 9 maintenance doses; doses to be given every 12 hours over a period of 5 days
Other Name: CytoFab™
Placebo Comparator: 3 Drug: Placebo


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Immunocompromising comorbidities or concomitant medications:

    1. Advanced human immunodeficiency virus (HIV) infection (CD4 ≤50/mm3).
    2. Stage III or IV cancer.
    3. Haemopoietic or lymphoreticular malignancies not in remission.
    4. Receiving radiation therapy or chemotherapy.
    5. Stem cell, organ or bone marrow transplant in the past 6 months.
    6. Absolute neutrophil count <500 per μL.
    7. High dose steroids or other immunocompromising drugs.
  • Concomitant diseases:

    1. Deep seated fungal infection or active tuberculosis.
    2. Cirrhosis with portal hypertension or Childs-Pugh Class C.
    3. History of chronic hypercarbia, respiratory failure in past 6 months or use of home oxygen in the setting of severe chronic respiratory disease.
    4. Neuromuscular disorders that impact breathing/spontaneous ventilation.
    5. Quadriplegia.
    6. Cardiac arrest in the past 30 days.
    7. New York Heart Association functional Class IV due to heart failure or any disorder.
    8. Burns over > 30% of body surface area.
  • Medication and allergy disqualifications.

    1. Treatment with anti-TNF agents within the last 8 weeks.
    2. Previously received ovine derived products (CroFab™, DigiFab™).
    3. Sheep product allergy or allergy to latex, papain, chymopapain.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01145560

  Hide Study Locations
Australia, New South Wales
Research Site
Blacktown, New South Wales, Australia
Research Site
Wollongong, New South Wales, Australia
Australia, Queensland
Research Site
Herston, Queensland, Australia
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Nambour, Queensland, Australia
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Woollongabba, Queensland, Australia
Australia, South Australia
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Adelaide, South Australia, Australia
Australia, Victoria
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Clayton, Victoria, Australia
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Footscray, Victoria, Australia
Australia, Western Australia
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Fremantle, Western Australia, Australia
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Antwerpen, Belgium
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Brussels, Belgium
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Genk, Belgium
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Godinne, Belgium
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Liege, Belgium
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Ottignies, Belgium
Canada, Alberta
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Edmonton, Alberta, Canada
Canada, British Columbia
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Vancouver, British Columbia, Canada
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Victoria, British Columbia, Canada
Canada, Manitoba
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Winnipeg, Manitoba, Canada
Canada, Nova Scotia
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Halifax, Nova Scotia, Canada
Canada, Ontario
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Ottawa, Ontario, Canada
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Windsor, Ontario, Canada
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Quebec, Canada
Czech Republic
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Hradec Kralove, Czech Republic
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Praha, Czech Republic
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Usti Nad Labem, Czech Republic
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Kuopio, Finland
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Tampere, Finland
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Angers, France
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Dijon, France
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La Roche Sur Yon, France
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Limoges, France
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Montauban, France
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Nantes, France
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Nimes, France
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Orleans, France
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Paris, France
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Poitiers, France
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Saint-michel, France
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Toulon, France
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Toulouse, France
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Tours, France
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Vandoeuvre Les Nancy, France
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Oviedo, Asturias, Spain
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Sabadell, Barcelona, Spain
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Barcelona, Cataluna, Spain
Research Site
Terrassa, Cataluna, Spain
Research Site
Valencia, Comunidad Valenciana, Spain
Research Site
Santiago de Compostela, Coruna, Spain
Research Site
Palma de Mallorca, Islas Baleares, Spain
Research Site
Getafe, Madrid, Spain
Research Site
Madrid, Spain
Sponsors and Collaborators
Principal Investigator: Gordon Bernard, MD Vanderbilt University
Study Director: Warren Botnick, MD Parexel
Study Director: Justin Lindemann, MD AstraZeneca
Study Director: Wayne Dankner, MD Parexel
Study Director: Jiri Juchelka, MD Parexel
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: AstraZeneca Identifier: NCT01145560     History of Changes
Other Study ID Numbers: D0620C00003
Study First Received: June 7, 2010
Results First Received: July 19, 2013
Last Updated: September 26, 2014

Keywords provided by AstraZeneca:
severe sepsis
TNF neutralisation
septic shock patients

Additional relevant MeSH terms:
Shock, Septic
Systemic Inflammatory Response Syndrome
Pathologic Processes processed this record on April 27, 2017