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A Study to Evaluate the Efficacy and Safety of Intravenous Ceftaroline Versus Intravenous Ceftriaxone in the Treatment of Adult Hospitalised Patients With Community-Acquired Bacterial Pneumonia in Asia

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01371838
First received: April 27, 2011
Last updated: November 28, 2014
Last verified: November 2014
Results First Received: May 28, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Community-Acquired Bacterial Pneumonia
Lung Infection of Individual Not Recently Hospitalized
Interventions: Drug: Ceftaroline
Drug: Ceftriaxone

  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
The enrollment period was from 13 December 2011 to 26 April 2013

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Enrolled patients (patients who gave informed consent) were screened for up to 24 hours to ensure eligibility before being randomized

Reporting Groups
  Description
Ceftaroline 600mg Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
Ceftriaxone 2g Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).

Participant Flow:   Overall Study
    Ceftaroline 600mg     Ceftriaxone 2g  
STARTED     381     383  
COMPLETED     332     317  
NOT COMPLETED     49     66  
Withdrawal by Subject                 27                 33  
Lost to Follow-up                 10                 20  
Death                 3                 4  
Protocol Violation                 3                 0  
Investigator Decision                 3                 8  
Last follow-up visit not conducted                 2                 0  
Lack of therapeutic response                 0                 1  
Surgery                 1                 0  



  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.
All randomized subjects who were intended to receive study treatment and were of PORT risk class III and IV. There was one patient with PORT risk class II who was not included in baseline analysis population.

Reporting Groups
  Description
Ceftaroline 600mg Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
Ceftriaxone 2g Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
Total Total of all reporting groups

Baseline Measures
    Ceftaroline 600mg     Ceftriaxone 2g     Total  
Number of Participants  
[units: participants]
  381     382     763  
Age  
[units: Years]
Mean ± Standard Deviation
  66.1  ± 14.70     65.8  ± 13.86     66.0  ± 14.28  
Age, Customized  
[units: Participants]
     
<65 years     155     146     301  
>=65 years     226     236     462  
Gender  
[units: Participants]
     
Female     116     110     226  
Male     265     272     537  
Race/Ethnicity, Customized  
[units: Participants]
     
Asian     381     382     763  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at Test of Cure (TOC) in CE Population   [ Time Frame: 7-20 days after last dose of study drug ]

2.  Secondary:   Clinical Response at End of Treatment (EOT) Visit in MITT Population   [ Time Frame: Last day of study drug administration ]

3.  Secondary:   Clinical Response at End of Treatment (EOT) Visit in CE Population   [ Time Frame: Last day of study drug administration ]

4.  Secondary:   Clinical Response at the Test of Cure (TOC) Visit in MITT Population   [ Time Frame: 7-20 days after last day of study drug administration ]

5.  Secondary:   Clinical Response at the Test of Cure (TOC) Visit in mMITT Population   [ Time Frame: 7-20 days after last day of study drug administration ]

6.  Secondary:   Clinical Response at the Test of Cure (TOC) Visit in ME Population   [ Time Frame: 7-20 days after last day of study drug administration ]

7.  Secondary:   Clinical Response at Test of Cure (TOC) Visit by Pathogen in ME Population   [ Time Frame: 7-20 days after last dose of study drug ]

8.  Secondary:   Per-Pathogen Microbiological Response at Test of Cure (TOC) Visit by Pathogen in ME Population   [ Time Frame: 7-20 days after last dose of study drug ]

9.  Secondary:   Per-Patient Microbiological Response at Test of Cure (TOC) Visit in mMITT Population   [ Time Frame: 7-20 days after last day of study drug administration ]

10.  Secondary:   Per-Patient Microbiological Response at Test of Cure (TOC) Visit in ME Population   [ Time Frame: 7-20 days after last day of study drug administration ]

11.  Secondary:   Overall (Clinical and Radiographic) Success Rate at Test of Cure (TOC) Visit in MITT Population   [ Time Frame: 7-20 days after last day of study drug administration ]

12.  Secondary:   Overall (Clinical and Radiographic) Success Rate at Test of Cure (TOC) Visit in CE Population   [ Time Frame: 7-20 days after last dose of study drug ]

13.  Secondary:   Clinical Relapse at the LFU Visit for Clinical Cure Patients at Test of Cure (TOC) Visit in MITT Population   [ Time Frame: 21-42 days after last day of study drug administration ]

14.  Secondary:   Clinical Relapse at the LFU Visit for Clinical Cure Patients at Test of Cure (TOC) Visit in CE Population   [ Time Frame: 21-42 days after last day of study drug administration ]

15.  Secondary:   Microbiological Re-infection/Recurrence at LFU Visit in mMITT Population   [ Time Frame: 21-42 days after last dose of study drug ]

16.  Secondary:   Microbiological Re-infection/Recurrence at LFU Visit in ME Population   [ Time Frame: 21-42 days after last dose of study drug ]


  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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Results Point of Contact:  
Name/Title: Melnick, David A / Exec Dir Med Science
Organization: AstraZeneca Pharmaceuticals
phone: +1 302 886 5627
e-mail: David.Melnick@astrazeneca.com


No publications provided


Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01371838     History of Changes
Other Study ID Numbers: D3720C00002
Study First Received: April 27, 2011
Results First Received: May 28, 2014
Last Updated: November 28, 2014
Health Authority: China: Food and Drug Administration
India: Drugs Controller General of India
South Korea: Korea Food and Drug Administration (KFDA)
Taiwan: Department of Health
Philippines: Bureau of Food and Drugs
Vietnam: Ministry of Health