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.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01145560
First received: June 7, 2010
Last updated: October 7, 2013
Last verified: October 2013
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    Number of ventilator-free days (VFDs)


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

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

  • Safety and Tolerability [ Time Frame: All study visits (over 90 days following first dose) ] [ Designated as safety issue: Yes ]
    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
Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01145560

  Show 52 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Gordon Bernard, MD Vanderbilt University
Study Director: Warren Botnick, MD PAREXEL International
Study Director: Justin Lindemann, MD AstraZeneca
Study Director: Wayne Dankner, MD PAREXEL International
Study Director: Jiri Juchelka, MD PAREXEL International
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01145560     History of Changes
Other Study ID Numbers: D0620C00003
Study First Received: June 7, 2010
Results First Received: July 19, 2013
Last Updated: October 7, 2013
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Canadian Institutes of Health Research
France: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
Spain: Ministry of Health

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

Additional relevant MeSH terms:
Sepsis
Toxemia
Shock
Shock, Septic
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on April 23, 2014