Vancomycin Versus Daptomycin for the Treatment of Methicillin-resistant Staphylococcus Aureus Bacteremia Due to Isolates With High Vancomycin Minimum Inhibitory Concentrations (MICs)

This study has been terminated.
(Low patient enrollment)
Sponsor:
Collaborators:
Henry Ford Health System
Cubist Pharmaceuticals
Information provided by (Responsible Party):
Leonard B. Johnson, St. John Health System, Michigan
ClinicalTrials.gov Identifier:
NCT01287832
First received: January 31, 2011
Last updated: January 16, 2014
Last verified: January 2014
Results First Received: December 2, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Bacteremia
Interventions: Drug: Vancomycin
Drug: Daptomycin

  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
High Dose Vancomycin Vancomycin dosed to achieve a trough of 15-20 microgram/mL vs. daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)
High-dose Daptomycin Daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)

Participant Flow:   Overall Study
    High Dose Vancomycin     High-dose Daptomycin  
STARTED     6     5  
COMPLETED     5     4  
NOT COMPLETED     1     1  
Adverse Event                 1                 0  
Death                 0                 1  



  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
High Dose Vancomycin Vancomycin vs. daptomycin: Vancomycin dosed to achieve a trough of 15-20 microgram/mL vs. daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)
High-dose Daptomycin Vancomycin vs. daptomycin: Vancomycin dosed to achieve a trough of 15-20 microgram/mL vs. daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)
Total Total of all reporting groups

Baseline Measures
    High Dose Vancomycin     High-dose Daptomycin     Total  
Number of Participants  
[units: participants]
  6     5     11  
Age  
[units: years]
Mean ± Standard Deviation
  61.8  ± 22.6     68.2  ± 10.2     64.7  ± 17.5  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     4     1     5  
>=65 years     2     4     6  
Gender  
[units: participants]
     
Female     2     0     2  
Male     4     5     9  
Region of Enrollment  
[units: participants]
     
United States     6     5     11  



  Outcome Measures

1.  Primary:   Number of Participants With Clinical Success at Test of Cure Visit.   [ Time Frame: 30-42 days post-treatment ]

2.  Secondary:   Adverse Event Rate in Each Arm, Including the Nephrotoxicity and Skeletal Muscle Toxicity   [ Time Frame: 30-42 days post-treatment ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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
No text entered.  


Results Point of Contact:  
Name/Title: Leonard Johnson MD
Organization: St. John Hospital and Medical Center
phone: 3133438823
e-mail: leonard.johnson@stjohn.org


No publications provided


Responsible Party: Leonard B. Johnson, St. John Health System, Michigan
ClinicalTrials.gov Identifier: NCT01287832     History of Changes
Other Study ID Numbers: SJ1210-01, IND 109,614
Study First Received: January 31, 2011
Results First Received: December 2, 2013
Last Updated: January 16, 2014
Health Authority: United States: Food and Drug Administration