Safety and Efficacy of IV CXA-101 and IV Ceftazidime in Patients With Complicated Urinary Tract Infections

This study has been completed.
Sponsor:
Information provided by:
Cubist Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00921024
First received: June 12, 2009
Last updated: January 28, 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 Urinary Tract Infection
Interventions: Drug: CXA-101
Drug: Ceftazidime

  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
Two subjects, one in each arm, did not receive treatment.

Reporting Groups
  Description
CXA-101 CXA-101: intravenous 1000 mg every 8 hours
Ceftazidime Ceftazidime: intravenous 1000 mg every 8 hours

Participant Flow:   Overall Study
    CXA-101     Ceftazidime  
STARTED     85     42  
COMPLETED     81     39  
NOT COMPLETED     4     3  
Lost to Follow-up                 2                 0  
Received concomittant therapy                 2                 0  
Withdrawal by Subject                 0                 3  



  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.
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Reporting Groups
  Description
CXA-101 CXA-101: intravenous 1000 mg every 8 hours
Ceftazidime Ceftazidime: intravenous 1000 mg every 8 hours
Total Total of all reporting groups

Baseline Measures
    CXA-101     Ceftazidime     Total  
Number of Participants  
[units: participants]
  85     42     127  
Age  
[units: years]
Mean (Standard Deviation)
  56.8  (19.78)     62.7  (19.74)     58.8  (19.88)  
Gender  
[units: participants]
     
Female     42     16     58  
Male     43     26     69  



  Outcome Measures
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1.  Primary:   Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-Treat (mMITT) Population   [ Time Frame: TOC; 6-9 days after last study drug administration ]

2.  Primary:   Microbiological Response at the TOC Visit in the Microbiologically Evaluable (ME) Population.   [ Time Frame: TOC; 6-9 days after last 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
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  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: Ian Friedland, MD; Chief Medical Officer, Calixa/Cubist Pharmaceuticals Inc
ClinicalTrials.gov Identifier: NCT00921024     History of Changes
Other Study ID Numbers: CXA 101-03
Study First Received: June 12, 2009
Results First Received: January 9, 2015
Last Updated: January 28, 2015
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board