A Pilot Study of Daptomycin for Antimicrobial Prophylaxis
Condition: Antimicrobial Prophylaxis
Intervention: daptomycin 6 mg/kg IV
Intervention description: 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)
Intervention MeSH terms: Daptomycin
Phase: Phase 4
Study type: Interventional
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: MRSA; Increased risk for infection

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.
    

Eligibility criteria:

        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