Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 19497 |
Not provided
Not provided
Not provided
Study closed. PI left the institution.
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goals of the study are to evaluate the feasibility of using daptomycin as a prophylactic antimicrobial agent in patients undergoing cardiac surgery, to determine the rates of surgical site infection, and to evaluate the occurrence of adverse events.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Daptomycin as a single preoperative dose within 30 minutes prior to surgery Dosage: if creatinine clearance ≥ 30 ml/min: 6 mg/kg IV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| daptomycin 6 mg/kg IV | Drug | daptomycin 6 mg/kg IV given during induction phase as a one-time prophylactic dose for patients undergoing cardiac valve replacement and coronary artery bypass grafting (CABG) who are at increased risk for infection due to methicillin-resistant Staphylococcus aureus (MRSA) |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Patients Receiving Antimicrobial Prophylaxis Within the Appropriate Timeframe Before Incision | 30 days after surgery |
Not provided
Not provided
INCLUSION CRITERIA: Patients will be eligible for inclusion in the study if they meet the following criteria:
Provide signed and dated informed consent and are willing to receive the study medication
Age ≥ 18 years of age
If a female of childbearing potential is willing to practice at least one method of birth control during treatment and for at least 28 days after treatment with study medication:
barrier methods of birth control (e.g., condoms, diaphragms together with spermicidal foam or gel, or presence of IUD) or
surgical sterilization, approved hormonal contraceptives (such as birth control pills, depo-Provera, or Lupron Depot), or IUD are all acceptable.
If a female of childbearing potential, serum HCG negative within 24 hours of scheduled surgery.
Planned cardiac surgery procedures meeting current Duke criteria to receive anti-microbial prophylaxis active against MRSA:
a. Patients will meet at least one of the following criteria which are the same as for prophylaxis with vancomycin: i. preoperative hospitalization > 48 hours ii. transfer to Duke from outside facility iii. previous history of MRSA iv. any patient deemed to be high risk for MRSA by the attending surgeon, due to a complicated past medical and/or surgical history
EXCLUSION CRITERIA: Patients who satisfy any of the following are not eligible for study enrollment.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Keith S Kaye, MD, MPH | DMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
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
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Antimicrobial Prophylaxis Administration With Daptomycin |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Antimicrobial Prophylaxis Administration With Daptomycin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rate of Patients Receiving Antimicrobial Prophylaxis Within the Appropriate Timeframe Before Incision | The study closed due to the departure of the principal investigator and the data analysis was not performed. | Posted | 30 days after surgery |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Antimicrobial Prophylaxis Administration With Daptomycin |
Not provided
Not provided
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yong Choi, Clinical Research Coordinator | Duke University Health System | 919-684-7584 | yong.choi@duke.edu |
Not provided
| ID | Term |
|---|---|
| D017576 | Daptomycin |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D055666 | Lipopeptides |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 0 |
| 11 |
| 0 |
| 11 |
Not provided
Not provided
| D008055 |
| Lipids |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |