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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
Results First Received: July 19, 2013  
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
Conditions: Severe Sepsis
Septic Shock
Interventions: Drug: AZD9773
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were screened and enrolled from approximately 100 centres worldwide.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
AZD9773 250/50 Units/kg AZD9773 250/50 units/kg IV
AZD9773 500/100 Units/kg AZD9773 500/100 units/kg IV     
Placebo Saline

Participant Flow:   Overall Study
    AZD9773 250/50 Units/kg     AZD9773 500/100 Units/kg     Placebo  
STARTED     100     100     100  
Received Treatment     99     98     99  
Completed Treatment     69 [1]   85 [2]   78 [3]
COMPLETED     96 [4]   96 [5]   98 [6]
NOT COMPLETED     4     4     2  
Withdrawal by Subject                 2                 1                 0  
Lost to Follow-up                 1                 1                 1  
No study drug by 24h after organ failure                 1                 0                 0  
Accidental unblinding of study treatment                 0                 1                 0  
False insurance information                 0                 1                 0  
Withdrawal of therapy                 0                 0                 1  
[1] 9 patients died during the treatment period without completing the full course of treatment.
[2] 8 patients died during the treatment period without completing the full course of treatment.
[3] 7 patients died during the treatment period without completing the full course of treatment.
[4] 20 patients died during the study. Death was not a reason for treatment or study discontinuation.
[5] 33 patients died during the study. Death was not a reason for treatment or study discontinuation.
[6] 27 patients died during the study. Death was not a reason for treatment or study discontinuation.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
AZD9773 250/50 Units/kg AZD9773 250/50 units/kg IV
AZD9773 500/100 Units/kg AZD9773 500/100 units/kg IV     
Placebo Saline
Total Total of all reporting groups

Baseline Measures
    AZD9773 250/50 Units/kg     AZD9773 500/100 Units/kg     Placebo     Total  
Number of Participants  
[units: participants]
  100     100     100     300  
Age  
[units: years]
Mean ± Standard Deviation
  64.4  ± 15.76     66.6  ± 14.61     64.1  ± 15.25     65.0  ± 15.21  
Gender  
[units: Participants]
       
Female     40     40     32     112  
Male     60     60     68     188  



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

2.  Secondary:   7-day Mortality   [ Time Frame: Over 7 days following first dose ]

3.  Secondary:   28-day Mortality   [ Time Frame: Over 28 days following first dose ]

4.  Secondary:   Safety and Tolerability   [ Time Frame: All study visits (over 90 days following first dose) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Justin Lindemann
Organization: AstraZeneca
e-mail: ClinicalTrialTransparency@astrazeneca.com


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: September 26, 2014
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