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A Pilot Study of Daptomycin for Antimicrobial Prophylaxis

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ClinicalTrials.gov Identifier: NCT00572260
Recruitment Status : Terminated (Study closed. PI left the institution.)
First Posted : December 13, 2007
Results First Posted : December 3, 2012
Last Update Posted : July 25, 2014
Sponsor:
Collaborator:
Cubist Pharmaceuticals LLC
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Condition Antimicrobial Prophylaxis
Intervention Drug: daptomycin 6 mg/kg IV
Enrollment 11
Recruitment Details Between 1/17/2008 and 9/15/2008, 124 subjects were identified as qualifying, 56 were referred and approached, 44 refused to participate, and 12 signed the ICF at Duke University Hospital inpatient care units.
Pre-assignment Details Between 1/17/2008 and 9/15/2008, among the 12 study subjects that signed the ICF, 11 subjects met the eligibility criteria and were enrolled in the study. One subject was disqualified due to weight > 150kg and was withdrawn from the study
Arm/Group Title Antimicrobial Prophylaxis Administration With Daptomycin
Hide Arm/Group Description [Not Specified]
Period Title: Overall Study
Started 11
Completed 11
Not Completed 0
Arm/Group Title Antimicrobial Prophylaxis Administration With Daptomycin
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
<=18 years
0
   0.0%
Between 18 and 65 years
5
  45.5%
>=65 years
6
  54.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants
60  (17)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
4
  36.4%
Male
7
  63.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants
11
1.Primary Outcome
Title Rate of Patients Receiving Antimicrobial Prophylaxis Within the Appropriate Timeframe Before Incision
Hide Description [Not Specified]
Time Frame 30 days after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
The study closed due to the departure of the principal investigator and the data analysis was not performed.
Arm/Group Title Patients Undergoing Cardiac Surgery
Hide Arm/Group Description:
Patients undergoing cardiac valve replacement and coronary artery bypass grafting
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Antimicrobial Prophylaxis Administration With Daptomycin
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Antimicrobial Prophylaxis Administration With Daptomycin
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Antimicrobial Prophylaxis Administration With Daptomycin
Affected / at Risk (%)
Total   0/11 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Antimicrobial Prophylaxis Administration With Daptomycin
Affected / at Risk (%)
Total   0/11 (0.00%) 
Premature termination of the study due to departure of the PI resulted in falling short of enrollment goal (enrolled - 11 enrolled/goal - 100) leading to uninterpretable data.
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: Yong Choi, Clinical Research Coordinator
Organization: Duke University Health System
Phone: 919-684-7584
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00572260     History of Changes
Other Study ID Numbers: Pro00000856
19497
First Submitted: December 12, 2007
First Posted: December 13, 2007
Results First Submitted: March 29, 2011
Results First Posted: December 3, 2012
Last Update Posted: July 25, 2014