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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01145560
Registration number
NCT01145560
Ethics application status
Date submitted
7/06/2010
Date registered
16/06/2010
Date last updated
6/10/2014
Titles & IDs
Public title
A Study to Compare the Efficacy and Safety of 2 Dosing Regimens of IV Infusions of AZD9773 (CytoFabâ„¢) With Placebo in Adult Patients With Severe Sepsis and/or Septic Shock
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Scientific 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 (CytoFabâ„¢) in Adult Patients With Severe Sepsis and/or Septic Shock
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Secondary ID [1]
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D0620C00003
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Severe Sepsis
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Septic Shock
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Condition category
Condition code
Infection
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Studies of infection and infectious agents
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Injuries and Accidents
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Poisoning
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Blood
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Other blood disorders
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Infection
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Other infectious diseases
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Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - AZD9773
Treatment: Drugs - Placebo
Experimental: 1 - AZD9773 250/50 units/kg
Experimental: 2 - AZD9773 500/100 units/kg
Placebo comparator: 3 -
Treatment: Drugs: 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
Treatment: Drugs: Placebo
Placebo
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Ventilator-free Days (VFDs) Over 28 Days
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Assessment method [1]
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Number of ventilator-free days (VFDs)
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Timepoint [1]
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Over 28 days following first dose
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Secondary outcome [1]
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7-day Mortality
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Assessment method [1]
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Number of patients who died over 7 days
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Timepoint [1]
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Over 7 days following first dose
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Secondary outcome [2]
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28-day Mortality
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Assessment method [2]
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Number of patients who died over 28 days
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Timepoint [2]
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Over 28 days following first dose
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Secondary outcome [3]
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Safety and Tolerability
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Assessment method [3]
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Number of patients with treatment-emergent adverse events
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Timepoint [3]
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All study visits (over 90 days following first dose)
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Eligibility
Key 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.
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Minimum age
18
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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 (CroFabâ„¢, DigiFabâ„¢).
3. Sheep product allergy or allergy to latex, papain, chymopapain.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/05/2012
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Sample size
Target
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Accrual to date
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Final
300
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Research Site - Blacktown
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Research Site - Wollongong
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Research Site - Herston
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Research Site - Nambour
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Research Site - Woollongabba
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Research Site - Adelaide
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Research Site - Clayton
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Research Site - Footscray
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Recruitment hospital [9]
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Research Site - Fremantle
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Recruitment postcode(s) [1]
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- Blacktown
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- Wollongong
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- Herston
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- Adelaide
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- Clayton
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- Footscray
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Recruitment postcode(s) [9]
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- Fremantle
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Recruitment outside Australia
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Belgium
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Antwerpen
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Belgium
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Brussels
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Belgium
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Genk
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Madrid
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Ethics approval
Ethics application status
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Summary
Brief summary
The primary purpose of this study to evaluate the effect of two different doses of AZD9773 (CytoFabâ„¢) 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.
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Trial website
https://clinicaltrials.gov/study/NCT01145560
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Trial related presentations / publications
Yates JW, Das S, Mainwaring G, Kemp J. Population pharmacokinetic/pharmacodynamic modelling of the anti-TNF-alpha 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.
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Public notes
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Contacts
Principal investigator
Name
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Gordon Bernard, MD
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Address
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Vanderbilt University
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT01145560
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