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Phase 2 Study of Safety, Efficacy, and Pharmacokinetics of Higher Doses of Daptomycin and Vancomycin in MRSA Bacteremia (HDSAB)

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ClinicalTrials.gov Identifier: NCT00695903
Recruitment Status : Terminated (terminated due to lack of enrollment)
First Posted : June 12, 2008
Results First Posted : December 6, 2011
Last Update Posted : March 24, 2017
Sponsor:
Information provided by (Responsible Party):
Cubist Pharmaceuticals LLC

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Endocarditis, Bacterial
Infective Endocarditis
Interventions: Drug: daptomycin
Drug: vancomycin

  Participant Flow

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 10 mg/kg Daptomycin 10 mg/kg Intravenously (IV) every 24 hours
Vancomycin High-dose Vancomycin 15 mg/kg IV, dosed to maintain trough serum concentrations of 15 to 20 μg/mL

Participant Flow for 2 periods

Period 1:   Had End of Therapy (EOT) Assessment
    Daptomycin 10 mg/kg   Vancomycin High-dose
STARTED   19   19 
Met Continuation Criteria   9   6 
COMPLETED   7   4 
NOT COMPLETED   12   15 
Randomized not treated                0                2 
No confirmed MRSA                9                9 
Adverse Event                1                0 
Withdrawal by Subject                1                1 
Physician Decision                0                1 
Protocol Violation                1                2 

Period 2:   Had Test of Cure (TOC) Assessment
    Daptomycin 10 mg/kg   Vancomycin High-dose
STARTED   7   4 
COMPLETED   5   3 
NOT COMPLETED   2   1 
Lack of Efficacy                1                0 
Lost to Follow-up                1                0 
Adverse Event                0                1 



  Baseline Characteristics

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
Daptomycin 10 mg/kg Daptomycin 10 mg/kg Intravenously (IV) every 24 hours
Vancomycin High-dose Vancomycin 15 mg/kg IV, dosed to maintain trough serum concentrations of 15 to 20 μg/mL
Total Total of all reporting groups

Baseline Measures
   Daptomycin 10 mg/kg   Vancomycin High-dose   Total 
Overall Participants Analyzed 
[Units: Participants]
 19   17   36 
Age [1] 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      16  84.2%      15  88.2%      31  86.1% 
>=65 years      3  15.8%      2  11.8%      5  13.9% 
[1] Safety Population. Two patients in the high-dose vancomycin arm were randomized but not treated and therefore not included in the safety population.
Sex: Female, Male [1] 
[Units: Participants]
Count of Participants
     
Female      6  31.6%      4  23.5%      10  27.8% 
Male      13  68.4%      13  76.5%      26  72.2% 
[1] Safety Population. Two patients in the high-dose vancomycin arm were randomized but not treated and therefore not included in the safety population.


  Outcome Measures

1.  Primary:   Number of Participants With Treatment-emergent Creatine Phosphokinase (CPK) Elevations   [ Time Frame: On therapy and up to 3 days post-therapy (treatment duration ranged from 2 to 43 days) ]

2.  Primary:   Number of Participants With Elevated Serum Creatinine   [ Time Frame: On therapy and up to 3 days post-therapy (treatment duration ranged from 2 to 43 days) ]

3.  Secondary:   Number of Participants With Treatment Cure at End of Therapy (EOT) Visit   [ Time Frame: End of Therapy (median day 12 and 6.5 in daptomycin and vancomycin modified intent-to treat population, respectively) ]

4.  Secondary:   Number of Participants With Treatment Cure at Test of Cure (TOC)/Safety Visit   [ Time Frame: Test of Cure (TOC) Visit (35 to 49 days post-therapy, approximately week 8) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
Because the study was terminated early due to lack of enrollment, there were not sufficient patients to provide meaningful analysis for the following secondary outcomes: persistent/recurrent bacteremia and time to defervescence/clearance.


  More Information

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: Medical Director
Organization: Cubist Pharmaceuticals
e-mail: ellie.hershberger@cubist.com



Responsible Party: Cubist Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT00695903     History of Changes
Other Study ID Numbers: 3009-013
DAP-HDSAB-07-05 ( Other Identifier: Cubist Study Number )
First Submitted: June 10, 2008
First Posted: June 12, 2008
Results First Submitted: August 23, 2011
Results First Posted: December 6, 2011
Last Update Posted: March 24, 2017