Antimicrobial Prophylaxis
Conditions
Keywords
MRSA, Increased risk for infection
Brief summary
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.
Interventions
DRUGdaptomycin 6 mg/kg IV
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)
Sponsors
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients will be eligible for inclusion in the study if they meet the following criteria: 1. Provide signed and dated informed consent and are willing to receive the study medication 2. Age ≥ 18 years of age 3. 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: 1. barrier methods of birth control (e.g., condoms, diaphragms together with spermicidal foam or gel, or presence of IUD) or 2. surgical sterilization, approved hormonal contraceptives (such as birth control pills, depo-Provera, or Lupron Depot), or IUD are all acceptable. * Rhythm, temperature, and verbal promise of abstinence are not acceptable methods of birth control. 4. If a female of childbearing potential, serum HCG negative within 24 hours of scheduled surgery. 5. 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. 1. Hypersensitivity to daptomycin 2. Inability to receive standard prophylaxis agents (cefuroxime and rifampin) for any reason 3. Staphylococcal bacteremia at the time of enrollment 4. Diagnosis of S. aureus or coagulase negative staphylococcus pacemaker/defibrillator infection within the preceding 18 months 5. Patient is undergoing emergency CABG 6. Weight \>150 kg or \<50kg 7. Patients considered unlikely to survive at least 7 days due to underlying illness. 8. Patients with creatinine clearance (CLcr) \< 30mL/min (calculated using the Cockcroft-Gault equation using actual body weight) 9. Severe neutropenia (absolute neutrophil count \<0.500x103 /µL) 10. Pregnant, nursing or lactating women (if patient is still of childbearing potential, a negative serum pregnancy test will be confirmed) 11. Patients considered unlikely to comply with study procedures or to return for the scheduled post treatment evaluation 12. Any other condition that in the opinion of an investigator, would confound or interfere with evaluation of safety or efficacy of the investigational medication, or prevent compliance with the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of Patients Receiving Antimicrobial Prophylaxis Within the Appropriate Timeframe Before Incision | 30 days after surgery |
Countries
United States
Participant flow
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
Participants by arm
| Arm | Count |
|---|---|
| Antimicrobial Prophylaxis Administration With Daptomycin | 11 |
| Total | 11 |
Baseline characteristics
| Characteristic | Antimicrobial Prophylaxis Administration With Daptomycin |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 6 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Age, Continuous | 60 years STANDARD_DEVIATION 17 |
| Region of Enrollment United States | 11 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
Primary
Rate of Patients Receiving Antimicrobial Prophylaxis Within the Appropriate Timeframe Before Incision
Time frame: 30 days after surgery
Population: The study closed due to the departure of the principal investigator and the data analysis was not performed.