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Phase 4 Efficacy and Safety Study of Cubicin® With and Without Combination Therapy in S. Aureus Infective Endocarditis (SAIE)

This study has been terminated.
(commitment completed)
Sponsor:
Information provided by (Responsible Party):
Cubist Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00638157
First received: March 12, 2008
Last updated: April 15, 2013
Last verified: April 2013
Results First Received: March 4, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Infective Endocarditis
Interventions: Drug: daptomycin
Drug: daptomycin and gentamicin

  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
Daptomycin Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus a
Daptomycin Plus Gentamicin Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus intravenous gentamicin 1mg/kg every 8 hours for the first 3 days of daptomycin therapy.

Participant Flow:   Overall Study
    Daptomycin     Daptomycin Plus Gentamicin  
STARTED     12     12  
Treated     10     12  
COMPLETED     5 [1]   8 [1]
NOT COMPLETED     7     4  
Adverse Event                 0                 1  
Clinical (symptomatic) failure                 1                 1  
Microbiological failure                 1                 0  
Lost to Follow-up                 1                 0  
Physician Decision                 1                 0  
Not Specified                 1                 2  
Randomized, not treated                 2                 0  
[1] 4 subjects completed study drug in this arm



  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.
Intent-to-Treat (ITT) Population used. Includes all randomized subjects.

Reporting Groups
  Description
Daptomycin Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus a "dummy" infusion of 0.9% normal saline every 8 hours for the first 3 days of daptomycin therapy.
Daptomycin Plus Gentamicin Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus intravenous gentamicin 1mg/kg every 8 hours for the first 3 days of daptomycin therapy.
Total Total of all reporting groups

Baseline Measures
    Daptomycin     Daptomycin Plus Gentamicin     Total  
Number of Participants  
[units: participants]
  12     12     24  
Age  
[units: years]
Mean ± Standard Deviation
  38.9  ± 10.93     45.3  ± 9.90     42.1  ± 10.71  
Gender  
[units: participants]
     
Female     3     5     8  
Male     9     7     16  



  Outcome Measures
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1.  Primary:   Summary of Clinically Significant Increases in Serum Creatinine by Visit   [ Time Frame: Baseline, EOT Visit, TOC ]

2.  Secondary:   Summary of the Investigator's Assessment of Clinical Response at the TOC Visit   [ Time Frame: TOC Visit ]


  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
As the study was terminated prematurely, conclusions that can be drawn from the efficacy results are limited.


  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: Ed Campanaro / Vice President, Clinical Operations
Organization: Cubist Pharmaceuticals
phone: 781-860-8318
e-mail: ed.campanaro@cubist.com


No publications provided


Responsible Party: Cubist Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00638157     History of Changes
Other Study ID Numbers: DAP-4IE-06-03
Study First Received: March 12, 2008
Results First Received: March 4, 2013
Last Updated: April 15, 2013
Health Authority: United States: Food and Drug Administration