Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study Comparing the Safety and Efficacy of Intravenous CXA-201 and Intravenous Meropenem in Complicated Intraabdominal Infections

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cubist Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01445678
First received: September 26, 2011
Last updated: January 15, 2015
Last verified: January 2015
Results First Received: January 9, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Complicated Intra-abdominal Infection
Interventions: Drug: CXA-201 and metronidazole
Drug: Meropenem

  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
No text entered.

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
CXA-201 and Metronidazole as Treatment for cIAI CXA-201 and metronidazole: CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days
Meropenem as Treatment for cIAI Meropenem: Meropenem IV infusion (1000mg q8h) for 4-14 days

Participant Flow:   Overall Study
    CXA-201 and Metronidazole as Treatment for cIAI     Meropenem as Treatment for cIAI  
STARTED     482     497  
COMPLETED     452     476  
NOT COMPLETED     30     21  
Adverse Event                 12                 8  
Lack of Efficacy                 0                 2  
Lost to Follow-up                 8                 5  
Protocol Violation                 1                 1  
Withdrawal by Subject                 9                 5  



  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
CXA-201 and Metronidazole as Treatment for cIAI CXA-201 and metronidazole: CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days
Meropenem as Treatment for cIAI Meropenem: Meropenem IV infusion (1000mg q8h) for 4-14 days
Total Total of all reporting groups

Baseline Measures
    CXA-201 and Metronidazole as Treatment for cIAI     Meropenem as Treatment for cIAI     Total  
Number of Participants  
[units: participants]
  389     417     806  
Age  
[units: years]
Mean ± Standard Deviation
  50.8  ± 18.25     50.4  ± 16.87     50.6  ± 17.54  
Gender  
[units: participants]
     
Female     171     169     340  
Male     218     248     466  



  Outcome Measures
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1.  Primary:   The Percentage of Subjects With Clinical Outcome of Cure at the Test of Cure (TOC) Visit in the Microbiological Intent to Treat (MITT) Population   [ Time Frame: TOC; 26-30 days after start of study drug administration ]

2.  Secondary:   The Percentage of Subjects With Microbiological Outcome of Success at the TOC Visit in the Microbiologically Evaluable (ME) Population   [ Time Frame: TOC; 26-30 days after start of study drug administration ]

3.  Secondary:   The Percentage of Subjects With Clinical Response at End of Therapy (EOT) Visit in the MITT Population   [ Time Frame: EOT; Within 24 hours of last study drug administration ]

4.  Secondary:   The Percentage of Subjects With Clinical Response at End of Therapy in the ME Population   [ Time Frame: EOT; Within 24 hours of last study drug administration ]

5.  Secondary:   The Percentage of Subjects With Clinical Response at Long Term Follow-Up (LFU) in the MITT Population   [ Time Frame: LFU; 38 to 45 days after first study drug administration ]

6.  Secondary:   The Percentage of Subjects With Clinical Response at LFU Visit in the ME Population   [ Time Frame: LFU; 38 to 45 days after first study drug administration ]


  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
Two identical P3 protocols were initiated (NCT01445678 and NCT01445665) subsequently, Cubist and FDA agreed that integrated data from the 2 protocols could be analyzed and reported in a single Clinical Study Report. These analyses are presented here.


  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: Dr. Obi Umeh, Vice President Global Medical Sciences
Organization: Cubist Pharmaceuticals, Inc.
phone: 781-860-8415
e-mail: obiamiwe.umeh@cubist.com


No publications provided


Responsible Party: Cubist Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01445678     History of Changes
Obsolete Identifiers: NCT01445665
Other Study ID Numbers: CXA-cIAI-10-09
Study First Received: September 26, 2011
Results First Received: January 9, 2015
Last Updated: January 15, 2015
Health Authority: United States: Food and Drug Administration