Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Pharmacokinetics of Daptomycin During Cardiopulmonary Bypass Surgery

This study has been completed.
Sponsor:
Collaborators:
Cubist Pharmaceuticals LLC
Hartford Hospital
Western University of Health Sciences
Information provided by (Responsible Party):
Los Angeles Biomedical Research Institute
ClinicalTrials.gov Identifier:
NCT00701636
First received: June 17, 2008
Last updated: July 19, 2016
Last verified: July 2016
Results First Received: March 28, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Late Effects of Surgery
Staphylococcus Aureus
Surgical Site Infection
Intervention: Drug: daptomycin

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
From July 2008 to August 2010, we recruited subjects undergoing CABG surgery at Harbor-UCLA Medical Center, a 400-bed tertiary-care county hospital.

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
Cases The first 15 subjects enrolled will receive the intervention drug daptomycin as surgical antibiotic prophylaxis.
Controls 15 subjects will be enrolled in the standard of care antibiotic group to serve as the controls. Controls will receive no experimental medications or treatments. The purpose of enrolling control patients was to serve as a reference group for intervention patients. Specifically cases and controls will be compared for changes in commonly collected hematologic parameters, creatinine, and CPK. Additionally, parameters collected during anesthesia will be compared. Controls will be matched to the intervention group by age (+/- 10 years), gender, and ethnicity.

Participant Flow:   Overall Study
    Cases   Controls
STARTED   15   15 
COMPLETED   15   15 
NOT COMPLETED   0   0 



  Baseline Characteristics
  Hide 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.
Our protocol says we will enroll 32 subjects, with the assumption that 2 may not finish the study, have protocol violations, or have data that is corrupt and unusable. Our target was 30 analyzable subjects. Since we had no subjects withdraw from the trial, and no protocol violations or data problems, we halted enrollment at 30 subjects.

Reporting Groups
  Description
Cases The first 15 subjects enrolled will receive the intervention drug daptomycin as surgical antibiotic prophylaxis.
Controls 15 subjects will be enrolled in the standard of care antibiotic group to serve as the controls. Controls will receive no experimental medications or treatments. The purpose of enrolling control patients was to serve as a reference group for intervention patients. Specifically cases and controls will be compared for changes in commonly collected hematologic parameters, creatinine, and CPK. Additionally, parameters collected during anesthesia will be compared. Controls will be matched to the intervention group by age (+/- 10 years), gender, and ethnicity.
Total Total of all reporting groups

Baseline Measures
   Cases   Controls   Total 
Overall Participants Analyzed 
[Units: Participants]
 15   15   30 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   12   12   24 
>=65 years   3   3   6 
Age 
[Units: Years]
Mean (Standard Deviation)
 56  (8.0)   57  (8.7)   56  (7.4) 
Gender 
[Units: Participants]
     
Female   3   2   5 
Male   12   13   25 
Region of Enrollment 
[Units: Participants]
     
United States   15   15   30 


  Outcome Measures

1.  Primary:   Mean Daptomycin Concentrations at 12, 18, 24, and 48 h   [ Time Frame: Hospital discharge or 7 days, whichever comes first ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Loren Miller MD
Organization: LA BioMed at Harbor-UCLA Medical Center
phone: 310-222-3813
e-mail: Lgmiller@ucla.edu


Publications of Results:

Responsible Party: Los Angeles Biomedical Research Institute
ClinicalTrials.gov Identifier: NCT00701636     History of Changes
Other Study ID Numbers: 12903-01
IIS 0003-07-2007 ( Other Identifier: Cubist Pharmaceuticals )
Study First Received: June 17, 2008
Results First Received: March 28, 2012
Last Updated: July 19, 2016
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
United States: Federal Government