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

September 26, 2014 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Blacktown, New South Wales, Australia
        • Research Site
      • Wollongong, New South Wales, Australia
        • Research Site
    • Queensland
      • Herston, Queensland, Australia
        • Research Site
      • Nambour, Queensland, Australia
        • Research Site
      • Woollongabba, Queensland, Australia
        • Research Site
    • South Australia
      • Adelaide, South Australia, Australia
        • Research Site
    • Victoria
      • Clayton, Victoria, Australia
        • Research Site
      • Footscray, Victoria, Australia
        • Research Site
    • Western Australia
      • Fremantle, Western Australia, Australia
        • Research Site
  • Belgium
      • Antwerpen, Belgium
        • Research Site
      • Brussels, Belgium
        • Research Site
      • Genk, Belgium
        • Research Site
      • Godinne, Belgium
        • Research Site
      • Liege, Belgium
        • Research Site
      • Ottignies, Belgium
        • Research Site
  • Canada
      • Quebec, Canada
        • Research Site
    • Alberta
      • Edmonton, Alberta, Canada
        • Research Site
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Research Site
      • Victoria, British Columbia, Canada
        • Research Site
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • Research Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Research Site
    • Ontario
      • Ottawa, Ontario, Canada
        • Research Site
      • Windsor, Ontario, Canada
        • Research Site
  • Czech Republic
      • Hradec Kralove, Czech Republic
        • Research Site
      • Praha, Czech Republic
        • Research Site
      • Usti Nad Labem, Czech Republic
        • Research Site
  • Finland
      • Kuopio, Finland
        • Research Site
      • Tampere, Finland
        • Research Site
  • France
      • Angers, France
        • Research Site
      • Dijon, France
        • Research Site
      • La Roche Sur Yon, France
        • Research Site
      • Limoges, France
        • Research Site
      • Montauban, France
        • Research Site
      • Nantes, France
        • Research Site
      • Nimes, France
        • Research Site
      • Orleans, France
        • Research Site
      • Paris, France
        • Research Site
      • Poitiers, France
        • Research Site
      • Saint-michel, France
        • Research Site
      • Toulon, France
        • Research Site
      • Toulouse, France
        • Research Site
      • Tours, France
        • Research Site
      • Vandoeuvre Les Nancy, France
        • Research Site
  • Spain
      • Madrid, Spain
        • Research Site
    • Asturias
      • Oviedo, Asturias, Spain
        • Research Site
    • Barcelona
      • Sabadell, Barcelona, Spain
        • Research Site
    • Cataluna
      • Barcelona, Cataluna, Spain
        • Research Site
      • Terrassa, Cataluna, Spain
        • Research Site
    • Comunidad Valenciana
      • Valencia, Comunidad Valenciana, Spain
        • Research Site
    • Coruna
      • Santiago de Compostela, Coruna, Spain
        • Research Site
    • Islas Baleares
      • Palma de Mallorca, Islas Baleares, Spain
        • Research Site
    • Madrid
      • Getafe, Madrid, Spain
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 3
Drug: Placebo
Placebo
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 Names:
  • 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 Names:
  • CytoFab™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ventilator-free Days (VFDs) Over 28 Days
Time Frame: Over 28 days following first dose
Number of ventilator-free days (VFDs)
Over 28 days following first dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
7-day Mortality
Time Frame: Over 7 days following first dose
Number of patients who died over 7 days
Over 7 days following first dose
28-day Mortality
Time Frame: Over 28 days following first dose
Number of patients who died over 28 days
Over 28 days following first dose
Safety and Tolerability
Time Frame: All study visits (over 90 days following first dose)
Number of patients with treatment-emergent adverse events
All study visits (over 90 days following first dose)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Warren Botnick, MD, Parexel
  • Study Director: Jiri Juchelka, MD, Parexel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (ACTUAL)

May 1, 2012

Study Completion (ACTUAL)

May 1, 2012

Study Registration Dates

First Submitted

June 7, 2010

First Submitted That Met QC Criteria

June 15, 2010

First Posted (ESTIMATE)

June 16, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

October 6, 2014

Last Update Submitted That Met QC Criteria

September 26, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D0620C00003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe