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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.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01145560
First received: June 7, 2010
Last updated: September 26, 2014
Last verified: September 2014
June 7, 2010
September 26, 2014
October 2010
May 2012   (Final data collection date for primary outcome measure)
Ventilator-free Days (VFDs) Over 28 Days [ Time Frame: Over 28 days following first dose ]
Number of ventilator-free days (VFDs)
Evaluate the effect of 2 different doses of AZD9773 on Ventilator-free days [ Time Frame: Over 28 days following first dose ]
Complete list of historical versions of study NCT01145560 on ClinicalTrials.gov Archive Site
  • 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
  • Evaluate the affect of AZD9773 on 7-day mortality in patients with severe sepsis or septic shock [ Time Frame: Over 7 days following first dose ]
  • Evaluate the affect of AZD9773 on 28-day mortality in patients with severe sepsis or septic shock [ Time Frame: Over 28 days following first dose ]
  • To characterize the safety and tolerability of AZD9773 in patients with severe sepsis or septic shock through the assessment of adverse events, mortality, ECGs, vital signs, laboratory tests, and physical examination [ Time Frame: Over 90 days following first dose ]
Not Provided
Not Provided
 
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
  • Severe Sepsis
  • Septic Shock
  • 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™
  • Drug: Placebo
    Placebo
  • Experimental: 1
    AZD9773 250/50 units/kg
    Intervention: Drug: AZD9773
  • Experimental: 2
    AZD9773 500/100 units/kg
    Intervention: Drug: AZD9773
  • Placebo Comparator: 3
    Intervention: Drug: Placebo
Yates JW, Das S, Mainwaring G, Kemp J. Population pharmacokinetic/pharmacodynamic modelling of the anti-TNF-α polyclonal fragment antibody AZD9773 in patients with severe sepsis. J Pharmacokinet Pharmacodyn. 2012 Dec;39(6):591-9. doi: 10.1007/s10928-012-9270-4. Epub 2012 Sep 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
May 2012
May 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   Canada,   Czech Republic,   Finland,   France,   Spain
Austria,   Germany,   United States
 
NCT01145560
D0620C00003
Not Provided
Not Provided
Not Provided
AstraZeneca
AstraZeneca
Not Provided
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
AstraZeneca
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP