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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

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ClinicalTrials.gov Identifier: NCT01145560
Recruitment Status : Completed
First Posted : June 16, 2010
Results First Posted : September 23, 2013
Last Update Posted : October 6, 2014
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Severe Sepsis Septic Shock Drug: AZD9773 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (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
Study Start Date : October 2010
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis Shock

Arms and Interventions
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Arm Intervention/treatment
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


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


Secondary Outcome Measures :
  1. 7-day Mortality [ Time Frame: Over 7 days following first dose ]
    Number of patients who died over 7 days

  2. 28-day Mortality [ Time Frame: Over 28 days following first dose ]
    Number of patients who died over 28 days

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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01145560


  Show 52 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
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
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Additional Information:
CSR-D0620C00003.pdf  This link exits the ClinicalTrials.gov site
redacted-CSP-D0620C00003.pdf  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01145560     History of Changes
Other Study ID Numbers: D0620C00003
First Posted: June 16, 2010    Key Record Dates
Results First Posted: September 23, 2013
Last Update Posted: October 6, 2014
Last Verified: September 2014

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